WHO DRUG

INFORMATION
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WHO Drug Information Vol 21, No. 2, 2007 World Health Organization

WHO Drug Information

Contents
Safety and Efficacy Issues Eculizumab approved for paroxysmal
Entecavir: not for use in HIV/HBV nocturnal haemoglobinuria 115
co-infection 87
Deferasirox: acute renal failure and Access to Medicines
cytopenias 87
Neglected tropical diseases 116
Safety of oseltamivir 87
Open access database for neglected
Fluticasone: reports of behavioural
medicines development 116
changes 88
Quetiapine: pancreatitis and thrombo-
cytopenia 88 Consultation Document
Aprotinin: hypersensitivity reactions and
renal dysfunction 89 International Pharmacopoeia
Metoclopramide in children: extra- Artemether and lumefantrine capsules 118
pyramidal symptoms 90 Magnesium sulfate injection 123
Drug-eluting stents: to be used with Zinc sulfate 124
caution 90 Paediatric zinc sulfate tablets 125
Darbepoetin alfa and epoetin alfa: update Paediatric zinc sulfate oral solution 127
for non-myeloid malignancies 91
Ayurvedic and Chinese medicines:
heavy metals 91
Recent Publications,
ADHD drugs: cardiovascular and psychi- Information and Events
atric events 92 Informed consent for research in resource-
Clozapine can impair motility of the entire poor settings 129
GI tract 93 Lessons learned in home management
of malaria 129
Developing drug information centres
Essential Medicines in India 130
15th Model List of Essential Medicines 94 First-in-man clinical trials for high risk
Model List of Essential Medicines, 15th products 130
Edition, revised March 2007 95 Pakistan Pharmacists Society
discussion forum 130
New quality assurance compendium 130
Regulatory Action and News Pharmacological management of human
Tegaserod: marketing suspension 112 H5N1 infection 131
Pergolide: voluntary withdrawal of
products 112
Aliskiren approved for hypertension 113 Proposed International
Lapatinib approved for breast cancer 114
Adalimumab approved for Crohn disease114 Nonproprietary Names:
133
Rapid test for meningitis cleared for List 97
marketing 114

85
World Health Organization WHO Drug Information Vol 21, No. 2, 2007

Announcement

The 13th International Conference

of Drug Regulatory Authorities (ICDRA)
will be hosted by the Swiss Agency for
Therapeutic Products (Swissmedic) in
collaboration with the World Health
Organization

The ICDRA will take place

in Berne, Switzerland
from 16 to 19 September 2008

Updated information will be provided regularly at:

http://www.icdra.ch

or

http://www.who.int/medicines/icdra/en/index/html

86
WHO Drug Information Vol 21, No. 2, 2007
Safety and Efficacy Issues
Entecavir : not for use in
HIV/HBV co-infection
European Union — The Committee for
Medicinal Products for Human Use
(CHMP) reminds healthcare professionals
that entecavir (Baraclude®) has not been
evaluated for the treatment of patients
with chronic hepatitis B virus (HBV) infec-
tion who are co-infected with the human
immunodeficiency virus (HIV) and are not
receiving highly active antiretroviral
therapy (HAART).
Based on new data, the EMEA advises
healthcare professionals that:
• Baraclude® has not been evaluated in
HIV/HBV co-infected patients not
simultaneously receiving effective HIV
treatment.
• When considering therapy with ente-
cavir in an HIV/HBV co-infected patient
not receiving HAART, there appears to
be a risk of developing HIV resistance.
• Until reassuring data become available,
Baraclude® should only be considered
in this setting under exceptional circum-
stances.
Reference: European Medicines Agency,
Public Statement, EMEA/79902/20075. March
2007.
Deferasirox: acute renal
failure and cytopenias
Canada — The manufacturer of defera-
sirox (Exjade®) has updated the safety
information regarding reports of acute
renal failure and peripheral blood cyto-
penias.
Deferasirox is indicated in the manage-
ment of chronic iron overload in patients
with transfusion-dependent anaemias
aged 6 years or older. It is also indicated
in the management of chronic iron over-
load in patients with transfusion-depend-
ent anaemias aged two to five who
cannot be adequately treated with
deferoxamine.
Therapy should be initiated and main-
tained by physicians experienced in the
treatment of chronic iron overload due to
blood transfusions.
Cases of acute renal failure (some with
fatal outcome) have been reported
following the post-marketing use of
deferasirox. For the fatal cases, it is
impossible to completely exclude a
contributory role of deferasirox to the
renal impairment The fact that there was
an improvement after stopping the
treatment in most of the cases with non-
fatal acute renal failure is suggestive of a
contributory role. Deferasirox has not
been studied in patients with renal impair-
ment.
Reference: Communication from Novartis
Pharmaceuticals Canada Inc. on Medeffect at
http://www.hc-sc.gc.ca
Safety of oseltamivir
European Union — The European
Medicines Agency (EMEA) has docu-
mented new reports of neuropsychiatric
adverse events occurring with the use of
oseltamivir (Tamiflu®) originating from
Japan. These cases have been detected
through routine safety monitoring.
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Safety and Efficacy Issues
The Agency’s Committee for Medicinal
Products for Human Use (CHMP) has
monitored closely all adverse drug
reactions reported in connection with the
use of oseltamivir since it was introduced
in the European Union in 2003.
The CHMP recommended an update of
the product information on neuropsychi-
atric side effects: “Convulsion, depressed
level of consciousness, abnormal behav-
iour, hallucinations and delirium have
been reported during Tamiflu® adminis-
tration, leading in rare cases to accidental
injury. Patients, especially children and
adolescents should be closely monitored
and their healthcare professional should
be contacted immediately if the patient
shows any signs of unusual behaviour.”
The EMEA and CHMP will continue to
closely monitor any emerging safety
information on Tamiflu®, including neuro-
psychiatric disorders. If any concerns
emerge, further action will be taken. With
these measures in place, the CHMP
maintains its opinion that the benefits of
Tamiflu® outweigh its risks when the
product is used according to the adopted
recommendations.
Reference: EMEA Press Release, 23 March
2007. Doc. Ref. EMEA/134566/2007. http://
www.emea.europa.eu
Fluticasone: reports of
behavioural changes
Netherlands — The Netherlands Phar-
macovigilance Centre, Lareb, has re-
ceived 17 reports of behavioural changes
in children associated with the use of
inhaled fluticasone propionate or
salmeterol/fluticasone propionate (4). In
11 cases, symptoms disappeared when
fluticasone propionate was withdrawn. A
positive rechallenge was observed in one
case. Six patients who had received
fluticasone propionate also received
salbutamol. However, in all but one case,
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WHO Drug Information Vol 21, No. 2, 2007
the reporter did not see a causal relation-
ship between the adverse drug reaction
and salbutamol. Psychiatric effects have
also been reported in association with the
use of oral corticosteroids and inhaled
budesonide, which raises the possibility
of a group effect.
Reference: Fluticasone inhalation and
behavioural changes in children. Lareb,
Netherlands Pharmacovigilance Centre,
January 2007 (www.lareb.nl).
Quetiapine: pancreatitis
and thrombocytopenia
Canada — Quetiapine (Seroquel®) is an
atypical antipsychotic drug indicated for
the management of symptoms of schizo-
phrenia and the acute management of
manic episodes associated with bipolar
disorder (1). In Canada, quetiapine has
been marketed since December 1997.
From 1997 to 2006, Health Canada has
received 615 domestic reports of adverse
reactions suspected of being associated
with the use of quetiapine. Nine reports
involved cases of pancreatitis and 11
involved cases of thrombocytopenia.
Neither of these ARs is mentioned in the
Canadian product monograph (1).
Pancreatitis
The 9 reported cases of pancreatitis
involved patients aged 24–71 years. In 5
cases, quetiapine was the only suspect
drug; in the other cases, reported co-
suspect drugs included medications that
have been associated with pancreatitis:
clozapine, divalproex sodium, fenofibrate
and minocycline (2, 3).
Acute pancreatitis typically presents as
an acute inflammation of the pancreas
that may or may not involve the surround-
ing tissues (2). Gallstones and heavy
alcohol use are the most common causes
(2). The severity of drug-induced pan-
creatitis is variable; the majority of pa-
WHO Drug Information Vol 21, No. 2, 2007
tients recover without any long-term
morbidity, but 5% –15% of patients
experience life-threatening complications
(4). People at risk of drug-induced pan-
creatitis include elderly patients taking
multiple medications, patients who are
HIV positive, patients who have cancer
and patients receiving immunomodulatory
agents (5).
Thrombocytopenia
The 11 reported cases of thrombocytope-
nia involved patients aged 28–84 years.
In 6 cases, quetiapine was the only
suspect drug. In 5 cases, reported co-
suspect drugs included medications that
have been associated with thrombocyto-
penia: citalopram, clozapine, olanzapine,
pantoprazole, rofecoxib and zuclopen-
thixol (6–12).
Thrombocytopenia is usually defined as a
platelet count of less than 150 x 109/L or
a 50% decrease in the platelet count from
baseline (6). Some reports define drug-
induced thrombocytopenia as a platelet
count of less than 100 x 109/L (6). Al-
though relatively rare, drug-induced
thrombocytopenia may be associated
with risks of morbidity and mortality (6).
Perhaps because of its low incidence
and idiosyncratic nature, drug-induced
thrombocytopenia has often gone unrec-
ognized during early clinical trials of drugs
and was first reported after marketing (6).
Extracted from Canadian Adverse Reaction
Newsletter, Volume 17, Number 2, 2007
References
1. Seroquel (quetiapine fumarate tablets)
[product monograph]. Mississauga (ON):
AstraZeneca Canada Inc.; 2006.
2. Eltookhy A, Pearson NL. Drug-induced
pancreatitis. Can Pharmacists J, 2006;139(6):
58–60.
3. Gropper D, Jackson CW. Pancreatitis
associated with quetiapine use. J Clin
Psychopharmacol, 2004;24(3):343–5.
Safety and Efficacy Issues
4. Kale-Pradhan PB, Conroy JL. Pancreatitis.
In: Drug-induced diseases: prevention,
detection, and management. Bethesda (MD):
American Society of Health-System Pharma-
cists, Inc.; 2005. p. 537–47.
5. Adverse Drug Reactions Advisory Commit-
tee (ADRAC). Drug induced pancreatitis. Aust
Adv Drug Reactions Bull, 2006;25(6):22.
6. Skirvin JA. Thrombocytopenia. In: Tisdale
JE, Miller DA, editors. Drug-induced diseases:
prevention, detection, and management.
Bethesda (MD): American Society of Health-
System Pharmacists, Inc.; 2005. p. 649–59.
7. Kentos A, Robin V, Lambermont M, et al.
Probable rofecoxib-induced thrombocytope-
nia. Rheumatology, 2003;42(5):699–700.
8. Hirshberg B, Gural A, Caraco Y. Zuclo-
penthixol-associated neutropenia and throm-
bocytopenia. Ann Pharmacother, 2000;34(6):
740–2.
9. Huynh M, Chee K, Lau DH. Thrombotic
thrombocytopenic purpura associated with
quetiapine. Ann Pharmacother, 2005;39(7–
8):1346-8.
10. Watson TD, Stark JE, Vesta KS.
Pantoprazole-induced thrombocytopenia. Ann
Pharmacother, 2006;40(4):758–61.
11. Celexa (citalopram hydrobromide tablets)
[product monograph]. Montreal: Lundbeck
Canada Inc.; 2006.
12. Clozaril (clozapine tablets) [product
monograph]. Dorval (QC): Novartis Pharma-
ceuticals Canada Inc.; 2006.
Aprotinin: hypersensitivity
reactions and renal
dysfunction
Canada — Health Canada has informed
hospitals and pharmacies of an associa-
tion of aprotinin (Trasylol®) with hyper-
sensitivity reactions and renal dysfunc-
tion. Aprotinin is indicated for prophylactic
use to reduce perioperative blood loss
and the need for blood transfusion in
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Safety and Efficacy Issues
those patients undergoing cardiopulmo-
nary bypass in the course of coronary
artery bypass graft (CABG) surgery who
are at increased risk for blood loss and
blood transfusion requirement.
The authorized indication for Trasylol® is
restricted to those patients undergoing
cardiopulmonary bypass in the course of
coronary artery bypass graft (CABG)
surgery who are at increased risk for
blood loss and blood transfusion.
Trasylol® administration may cause fatal
and nonfatal anaphylactic or anaphylac-
toid reactions. Fatal reactions have
occurred with an initial (test) dose as well
as with any of the components of the
dose regimen. Fatal reactions have also
occurred in situations where the initial
(test) dose was tolerated. As a result,
Trasylol® should only be administered in
operative settings where cardiopulmonary
bypass can be rapidly initiated.
The risk for anaphylactic or anaphylactoid
reactions is increased among patients
with prior aprotinin exposure, and a
history of any prior aprotinin exposure
must be sought prior to Trasylol® admin-
istration. The risk for a fatal reaction
appears to be greater upon re-exposure.
As a result, administration of Trasylol® to
patients with a known or suspected
previous aprotinin exposure during the
last 12 months is contraindicated.
Trasylol® administration increases the
risk of renal dysfunction and may in-
crease the need for dialysis in the
perioperative period. This risk may be
especially increased for patients with pre-
existing renal impairment or those who
receive aminoglycoside antibiotics or
drugs that alter renal function.
Reference: Information Update 2007-36, 31
March 2007: Communication from Bayer Inc.
on http://.www.hc-sc.gc.ca
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WHO Drug Information Vol 21, No. 2, 2007
Metoclopramide in children:
extrapyramidal symptoms
Netherlands — Following an increase in
the number of registered cases of ex-
trapyramidal symptoms in children
receiving metoclopramide, the Medicines
Evaluation Board has restricted the use of
metoclopramide in this population to
treatment of severe nausea and vomiting
of known origin, and only if treatment with
other products is ineffective or is not
possible.
The MEB considers there are better
alternatives to metoclopramide. For
example, domperidone is a better choice
in treating post-operative nausea in
children. Domperidone is also the drug of
choice in treating migraine in children
because the risk of extrapyramidal effects
is lower than with metoclopramide.
Similarly, 5-HT3 receptor antagonists
(e.g. ondansetron) are the drugs of
choice in nausea due to strongly emeto-
genic chemotherapy because of better
efficacy and fewer adverse events.
Reference: News and Publications. The
Medicines Evaluation Board, the Netherlands,
21 February 2007. http://www.cbg-meb.nl/uk/
nieuws
Drug-eluting stents:
to be used with caution
Sweden — The Swedish Medical Prod-
ucts Agency (MPA), in conjunction with
the National Board of Health and Welfare
and the Swedish Society of Cardiology,
has recommended utmost restraint in the
use of drug-eluting stents. The recom-
mendation was based on the results of
clinical studies, including the Swedish
Coronary and Angioplasty Registry
(SCAAR) study that showed increased
risk of thrombosis associated with the use
of drug-eluting stents. The results of the
SCAAR study and four other randomized
studies showed that drug-eluting stents
WHO Drug Information Vol 21, No. 2, 2007
have no advantages in terms of myocar-
dial infarction or mortality, compared with
bare-metal stents; in addition, the SCAAR
study data indicated a small, long-term
increased risk of these events. According
to the MPA, drug-eluting stents must only
be used in patients for whom no other
treatment alternative exists or in patients
who are at greatly increased risk of
restenosis and for whom the effect of
restenosis is expected to be severe.
Reference: Swedish Medical Products
Agency, 13 February 2007. http://www.lake-
medelesverket.se.
Darbepoetin alfa and epoetin
alfa: update for non-myeloid
malignancies
Canada — The manufacturers of the
erythropoiesis-stimulating agents (ESAs),
have updated safety information based
on completed or ongoing clinical studies
regarding treatment with darbepoetin alfa
(Aranesp®) and epoetin alfa (Eprex®).
Darbepoetin alfa is indicated for the
treatment of anaemia associated with
chronic renal failure, and for the treatment
of anaemia in patients with non-myeloid
malignancies, where anaemia is due to
the effect of concomitantly administered
chemotherapy.
Epoetin alfa (Eprex®) is indicated for the
treatment of anaemia associated with
chronic renal failure, the treatment of
anaemia in patients with non-myeloid
malignancies, where anaemia is due to
the effect of concomitantly administered
chemotherapy, the treatment of anaemia
in zidovudine-treated/HIV-infected pa-
tients, and for the treatment of patients
undergoing major elective surgery to
facilitate autologous blood collection, and
to reduce allogeneic blood exposure.
Epoetin alfa is no longer indicated in the
treatment of anaemia in patients with
non-myeloid malignancies, where anae-
Safety and Efficacy Issues
mia is due to the disease itself. Therefore,
none of the ESAs are indicated in this
patient population. Recent clinical studies
have provided new safety information
regarding the use of ESAs, including risks
of tumour progression and serious
cardiovascular events.
ESAs increased the risk of death and of
serious cardiovascular adverse events in
patients with cancer or renal failure, when
treated to a target haemoglobin level of
greater than 120 g/L.
An increased risk of death was seen in
cancer patients with active malignant
disease, who were not being treated with
either radiation or chemotherapy and who
were treated with ESAs to a target
haemoglobin level of 120 g/L. ESAs are
not indicated in this patient population.
ESAs shortened the time to tumour
progression in patients with advanced
head and neck cancer receiving radiation
therapy; in addition, ESAs decreased
overall survival and increased deaths at
4 months, attributed to disease progres-
sion in patients with metastatic breast
cancer receiving chemotherapy, when
these groups of patients were treated to a
target haemoglobin level of greater than
120 g/L.
Reference: Communication from Amgen
Canada, Inc. 16 April 2007 on http://www.hc-
sc.gc.ca
Ayurvedic and Chinese
medicines: heavy metals
Australia — The Therapeutic Goods
Administration (TGA) has released a
statement about the safety of Ayurvedic
medicines in Australia, in response to
recent research into the toxic content of
heavy metals found in some Ayurvedic
medicines (1).
There are several possible explanations
for the presence of heavy metals in
traditional herbal remedies (2). Salts of
91
Safety and Efficacy Issues
heavy metals (for example those of lead,
mercury and arsenic) are used as princi-
pal ingredients in some traditional Indian
and (to a lesser extent) Chinese herbal
remedies (4). In addition, cross-contami-
nation of ingredients can occur between
these types of products and products not
intended to contain metal salts if manu-
facturing conditions are not controlled.
The possibility of contamination and
adulteration should be considered for any
herb or herbal medicine purchased over-
seas or imported for personal use, or
obtained over the internet.
Extracted from Australian Adverse Drug
Reactions Bulletin, Volume 26, Number 1,
2007
References
1. Safety of Ayurvedic medicine in Australia.
www.tga.gov.au/cm/ayurvedic.htm
2. Ernst E. Contamination of herbal medicines.
The Pharmaceutical Journal 2005; 275; 167
3. Pharmacopoeia of the People’s Republic of
China. Beijing, China: People’s Medical
Publishing House 2005.
ADHD drugs: cardiovascular
and psychiatric events
United States of America — The Food
and Drug Administration (FDA) has
directed the manufacturers of all drug
products approved for the treatment of
Attention Deficit Hyperactivity Disorder
(ADHD) to develop Patient Medication
Guides concerning risks of possible
cardiovascular and psychiatric events.
An FDA review of reports of serious
cardiovascular adverse events in patients
taking usual doses of ADHD products
revealed reports of sudden death in
patients with underlying serious heart
problems or defects, and reports of stroke
and heart attack in adults with certain risk
factors.
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WHO Drug Information Vol 21, No. 2, 2007
Another FDA review of ADHD medicines
revealed a slight increased risk (about 1
per 1000) for drug-related psychiatric
adverse events, such as hearing voices,
becoming suspicious for no reason, or
becoming manic, even in patients who
did not have previous psychiatric prob-
lems.
The medicines that are the focus of the
revised labelling and new Patient Medi-
cation Guides include the following:
Adderall® (mixed salts of a single entity
amphetamine product) Tablets
Adderall® XR (mixed salts of a single entity
amphetamine product) Extended-Release
Capsules
Concerta® (methylphenidate hydrochloride)
Extended-Release Tablets
Daytrana® (methylphenidate) Transdermal
System
Desoxyn® (methamphetamine HCl) Tablets
Dexedrine® (dextroamphetamine sulfate)
Spansule® Capsules and Tablets
Focalin® (dexmethylphenidate hydrochlo-
ride) Tablets
Focalin® XR (dexmethylphenidate hydro-
chloride) Extended-Release Capsules
Metadate® CD (methylphenidate hydrochlo-
ride) Extended-Release Capsules
Methylin® (methylphenidate hydrochloride)
Oral Solution
Methylin® (methylphenidate hydrochloride)
Chewable Tablets
Ritalin® (methylphenidate hydrochloride)
Tablets
Ritalin® SR (methylphenidate hydrochlo-
ride) Sustained-Release Tablets
WHO Drug Information Vol 21, No. 2, 2007 Safety and Efficacy Issues

Ritalin® LA (methylphenidate hydrochloride) tion may be associated with serious

Extended-Release Capsules effects such as intestinal obstruction,
Strattera® (atomoxetine HCl) Capsules bowel perforation and toxic megacolon.

Reference: FDA News, P07-26, 21 February In addition to reports of constipation

2007 with draft Patient Medication Guides for
each product at http://www.fda.gov/cder/drug/
infopage/ADHD/default.htm.
Clozapine can impair motility
of the entire GI tract
New Zealand — Clozapine (Clozaril®,
Clopine®) is an atypical antipsychotic that
is effective for treatment-resistant schizo-
phrenia. It causes agranulocytosis in up
to 1% of patients (1) and regular monitor-
ing of neutrophil counts is mandatory
throughout treatment. In New Zealand
one death from agranulocytosis has been
reported. In contrast, four deaths from
complications of severe constipation have
been reported to the Intensive Medicines
Monitoring Programme. Health profes-
sionals are reminded that the gastro-
intestinal (GI) effects of clozapine are
potentially serious.
Constipation is often regarded as a
frequent, minor side effect of clozapine.
However, review of New Zealand reports
shows that clozapine-induced constipa-
associated with clozapine, there have
been three reports of paralytic ileus and a
further three reports of oesophageal
dysmotility. These case reports suggest
that clozapine may reduce GI motility
throughout the gut, resulting in complica-
tions higher in the GI tract.
Many anticholinergic drugs can cause GI
dysmotility, but clozapine has a much
more potent effect through its interaction
with multiple receptors (including anti-
cholinergic and serotonergic receptors)
affecting GI activity. This action is exacer-
bated by co-prescription of anticholinergic
agents such as benztropine and tricyclic
antidepressants.
References
1. Alvir JMJ, Lieberman JA, Safferman AZ, et
al. Clozapine-induced agranulocytosis. New
England Journal of Medicine 1993;329:162-
167
2. PM Ellis. Clozapine: Fatal ‘constipation’
more common than fatal agranulocytosis.
Prescriber Update. March 2007. http://
www.medsafe.govt.nz

Spontaneous monitoring systems are useful in detecting signals of relatively rare, serious and unexpected adverse
drug reactions. A signal is defined as "reported information on a possible causal relationship between an adverse event
and a drug, the relationship being unknown or incompletely documented previously. Usually, more than a single report
is required to generate a signal, depending upon the seriousness of the event and the quality of the information". All
signals must be validated before any regulatory decision can be made.

93

Essential Medicines
15th Model List
of Essential Medicines
Model List updated
The WHO Model List of Essential Medi-
cines allows countries to select medicines
of public health priority, address problems
of cost and availability and provides guid-
ance to pharmaceutical manufacturers on
medicine needs.
During its 2007 meeting in Geneva, the
WHO Expert Committee on Essential
Medicines made a number of important
updates to the Model List of Essential
Medicines (set out on the following
pages). These included the addition of
five fixed-dose-combinations to treat HIV/
AIDS in adults, two of which are available
in generic form, and antimalarials recom-
mended by WHO.
Five oral liquid formulations were in-
cluded for children — three for epilepsy,
one for children born prematurely, and
one new medicine for HIV/AIDS. Three
other epilepsy medicines were included in
the form of chewable, dispersable tablets
which are also effective in children.
A medicines list for children
Following recommendations from the
Expert Committee, work will begin to
create a list if essential medicines specifi-
cally tailored to children’s needs. A group
of experts will meet in July 2007 to begin
work on a list of medicines to address
diseases of high mortality and morbidity
in children.
Children suffer from the same illnesses
as adults but they are more seriously
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WHO Drug Information Vol 21, No. 2, 2007
affected by certain conditions such as
respiratory tract infections, malaria and
diarrhoeal diseases — particularly in
developing countries. An estimated 10.6
million children under five die every year,
many from treatable conditions. In 2005,
2.3 million children under 15 years were
HIV positive.
In spite of the huge need, there are few
formulations appropriate for children or
that can be easily consumed by a child.
At present, children must often take
crushed adult tablets, with little evidence
to guide the efficacy and safety of the
dose. When medicines do exist in the
right dosage they are usually in syrup
form, which may pose supply, storage
and pricing problems in developing
countries.
The challenge for children becomes more
acute when they are affected by a condi-
tion requiring combination therapy, such
as HIV/AIDS and malaria. In these cases,
fixed dose combination tablets are re-
quired. While production of adult fixed-
dose-combinations is increasing, these
are lacking for children. In addition, anti-
retrovirals for children are currently three
times more expensive than the adult
versions.
WHO will also work with partners to
advocate innovation and research into
children’s medicines, manufacture of new
dosage forms and new formulas, and
mechanisms to relay information about
children’s medicines to countries quickly
and effectively.
Reference: WHO News Release. WHO/17. 13
April 2007 http://www.who.int
WHO Drug Information Vol 21, No. 2, 2007

WHO Model List of Essential Medicines

15th Edition, revised March 2007

Explanatory Notes
The core list presents a list of minimum medicine needs for a basic health care system, listing
the most efficacious, safe and cost-effective medicines for priority conditions. Priority condi-
tions are selected on the basis of current and estimated future public health relevance, and
potential for safe and cost-effective treatment.

The complementary list presents essential medicines for priority diseases, for which special-
ized diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training
are needed. In case of doubt medicines may also be listed as complementary on the basis of
consistent higher costs or less attractive cost-effectiveness in a variety of settings.

The square box symbol (■ ) is primarily intended to indicate similar clinical performance within
a pharmacological class. The listed medicine should be the example of the class for which
there is the best evidence for effectiveness and safety. In some cases, this may be the first
medicine that is licensed for marketing; in other instances, subsequently licensed compounds
may be safer or more effective. Where there is no difference in terms of efficacy and safety
data, the listed medicine should be the one that is generally available at the lowest price,
based on international drug price information sources. Therapeutic equivalence is only indi-
cated on the basis of reviews of efficacy and safety and when consistent with WHO clinical
guidelines. National lists should not use a similar symbol and should be specific in their final
selection, which would depend on local availability and price. Medicines are listed in alphabeti-
cal order, within sections.

The presence of an entry on the Essential Medicines List carries no assurance as to pharma-
ceutical quality. It is the responsibility of each local regulatory authority to ensure that each
brand is of appropriate pharmaceutical quality (including stability) and that, when relevant,
different brands are interchangeable.

Dosage forms of medicines are listed in alphabetical order and there is no implication of pref-
erence for one form over another. Standard treatment guidelines should be consulted for infor-
mation on appropriate dosage forms.

Entries of the type oral liquid are intended to permit any solution, suspension or other form of
liquid. Granules for reconstitution as an oral liquid may substitute for oral liquids, and typically
carry benefits in the form of better stability and lower transport costs. If more than one type of
oral liquid is available on the same market (e.g. solution, suspension, granules for reconstitu-
tion), they may be interchanged and in such cases should be bioequivalent. It is preferable that
oral liquids do not contain sugar, and that solutions for children do not contain alcohol.

Entries of the type tablet are intended to allow various forms of immediate-release tablet such
as uncoated, film-coated, crushable, chewable, dispersible etc. Enteric coating, on the other
hand, modifies drug release, and enteric-coated products are a modified release dosage form.
Crushable, chewable and dispersible tablets may be easier to administer to paediatric popula-
tions and to the elderly.

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15th Model List of Essential Medicines
1. Anaesthetics
1.1 General anaesthetics and oxygen
■ halothane inhalation
ketamine injection: 50 mg
(as hydrochloride)/
ml in 10-ml vial
nitrous oxide inhalation
oxygen inhalation (medicinal gas)
■ thiopental powder for injection: 0.5 g,
1.0 g (sodium salt) in ampoule
1.2 Local anaesthetics
■ bupivacaine Injection: 0.25%; 0.5%
(hydrochloride) in via.
Injection for spinal anaesthesia:
0.5% (hydrochloride) in 4-ml ampoule
to be mixed with 7.5% glucose solution
■ lidocaine Injection: 1%; 2%
(hydrochloride) in vial
Injection for spinal anaesthesia:
5% (hydrochloride) in 2-ml ampoule
to be mixed with 7.5% glucose solution
Topical forms: 2–4% (hydrochloride)
lidocaine + epinephrine Dental cartridge:
(adrenaline) 2% (hydrochloride) +
epinephrine 1:80 000
Injection: 1%; 2% (hydrochloride) +
epinephrine 1:200 000 in vial
Complementary List
ephedrine Injection: 30 mg (hydro-
chloride)/ml in 1-ml ampoule
(For use in spinal anaesthesia
during delivery, to prevent
hypotension)
1.3 Preoperative medication and sedation
for short-term procedures
atropine Injection: 1 mg (sulfate)
in 1-ml ampoule
■ diazepam Injection: 5 mg/ml in 2-ml ampoule
Tablet: 5 mg
morphine Injection: 10 mg (sulfate or
hydrochloride) in 1-ml ampoule
promethazine Oral liquid: 5 mg
(hydrochloride)/5 ml
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WHO Drug Information Vol 21, No. 2, 2007
2. Analgesics, antipyretics, non-
steroidal anti-inflammatory
medicines (NSAIMs), medi-
cines used to treat gout and
disease modifying agents in
rheumatoid disorders
(DMARDs)
2.1 Nonopioids and nonsteroidal anti-
inflammatory medicines (NSAIMs)
acetylsalicylic acid Suppository: 50–150 mg
Tablet: 100–500 mg
ibuprofen Tablet: 200 mg; 400 mg
paracetamol* Oral liquid: 125 mg/5 m
Suppository: 100 mg
Tablet: 100–500 mg
* Not recommended for anti-inflammatory use due
to lack of proven benefit to that effect.
2.2 Opioid analgesics
codeine Tablet: 30 mg (phosphate)
morphine Injection: 10 mg (morphine
hydrochloride or morphine
sulfate) in 1-ml ampoule
Oral liquid: 10 mg (morphine
hydrochloride or morphine
sulfate)/5 ml
Tablet: 10 mg (morphine sulfate)
Tablet (prolonged release): 10 mg;
30 mg; 60 mg (morphine sulfate)
2.3 Medicines used to treat gout
allopurinol Tablet: 100 mg
2.4 Disease modifying agents used in
rheumatoid disorders (DMARDs)
chloroquine Tablet: 100 mg; 150 mg
(as phosphate or sulfate).
Complementary List
azathioprine Tablet: 50 mg
methotrexate Tablet: 2.5 mg (as sodium salt)
penicillamine Capsule or tablet: 250 mg
sulfasalazine Tablet: 500 mg
WHO Drug Information Vol 21, No. 2, 2007 15th Model List of Essential Medicines

3. Antiallergics and medi- sodium nitrite Injection: 30 mg/ml

in 10-ml ampoule
cines used in anaphylaxis
sodium thiosulfate Injection: 250 mg/ml
■ chlorphenamine Injection: 10 mg (hydrogen in 50-ml ampoule
maleate) in 1-ml ampoule

Tablet: 4 mg (hydrogen maleate) 5. Anticonvulsants/anti-

epileptics
dexamethasone Injection: 4 mg dexamethasone
phosphate (as disodium salt) carbamazepine Oral liquid: 100 mg/5 ml
in 1-ml ampoule
Tablet (chewable):
epinephrine (adrenaline) Injection: 1 mg (as 100 mg; 200 mg
hydrochloride or hydrogen
tartrate) in 1-ml ampoule Tablet (scored): 100 mg; 200 mg

hydrocortisone Powder for injection: 100 mg ■ diazepam Injection: 5 mg/ml in 2-ml

(as sodium succinate) in vial ampoule (intravenous or rectal)
■ prednisolone* Tablet: 5 mg; 25 mg magnesium sulfate* Injection: 500 mg/ml in
2-ml ampoule; 500 mg/ml in
* There is no evidence for complete clinical simil- 10-ml ampoule
arity between prednisolone and dexamethasone at
high doses. * For use in eclampsia and severe pre-eclampsia and
not for other convulsant disorders.
4. Antidotes and other sub- phenobarbital Injection: 200 mg/ml
stancess used in poisonings (phenobarbital sodium)
Oral liquid: 15 mg/5 ml (phenobarbital)
4.1 Non-specific or 5 ml (phenobarbital sodium)
charcoal, activated Powder
Tablet: 15-100 mg (phenobarbital)
4.2 Specific
phenytoin Capsule: 25 mg; 50 mg;
acetylcysteine Injection: 200 mg/ml in 100 mg (sodium salt)
10-ml ampoule Injection: 50 mg/ml
in 5-ml vial (sodium salt)
atropine Injection: 1 mg (sulfate) in
1-ml ampoule Oral liquid: 25-30 mg/5 ml.*

calcium gluconate Injection: 100 mg/ml in Tablet: 25 mg; 50 mg;

10-ml ampoule 100 mg (sodium salt)
deferoxamine Powder for injection: 500 mg Tablet (chewable): 50 mg
(mesilate) in vial
* The presence of both 25 mg/5 ml and 30 mg/5 ml
dimercaprol Injection in oil: 50 mg/ml strengths on the same market would cause confu-
in 2-ml ampoule sion in prescribing and dispensing and should be
avoided.
DL-methionine Tablet: 250 mg
valproic acid Oral liquid: 200 mg/5 ml
methylthioninium chloride Injection: 10 mg/ml in
(methylene blue) 10-ml ampoule Tablet (crushable): 100 mg

naloxone Injection: 400 micrograms Tablet (enteric-coated): 200 mg;

(hydrochloride) in 1-ml ampoule 500 mg (sodium valproate)

penicillamine Capsule or tablet: 250 mg Complementary List

potassium ferric hexacyano- Powder for oral ethosuximide Capsule: 250 mg
ferrate(II) -2H20 (Prussian blue) administration
Oral liquid: 250 mg/5 ml
sodium calcium edetate Injection: 200 mg/ml
in 5-ml ampoule

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6. Anti-infective medicines ampicillin Powder for injection: 500 mg;

1 g (as sodium salt) in vial
6.1 Anthelminthics benzathine benzylpenicillin Powder for injection:
6.1.1 Intestinal anthelminthics 1.44 g benzylpenicillin
(=2.4 million IU) in 5-ml vial
albendazole Tablet (chewable): 400 mg
benzylpenicillin Powder for injection: 600 mg
levamisole Tablet: 50 mg; 150 mg (= 1 million IU); 3 g (= 5 million IU)
(as hydrochloride) (sodium or potassium salt) in vial

■ mebendazole Tablet (chewable): 100 mg; cefazolin* Powder for injection: 1 g

500 mg (as sodium salt) in vial

niclosamide* Tablet (chewable): 500 mg * For surgical prophylaxis.

* Niclosamide is listed for use when praziquantel cefixime* Capsule: 400 mg
treatment fails.
* Only listed for single-dose treatment of uncompli-
praziquantel Tablet: 150 mg; 600 mg cated ano-genital gonorrhoea.
pyrantel Oral liquid: 50 mg (as embonate)/ml ■ cloxacillin Powder for injection: 500 mg
(as sodium salt) in vial
Tablet (chewable): 250 mg
(as embonate) Capsule: 500 mg; 1 g (as sodium salt)
6.1.2 Antifilarials Powder for oral liquid: 125 mg
(as sodium salt)/5 ml
ivermectin Tablet (scored): 3 mg; 6 mg
phenoxymethylpenicillin Powder for oral liquid:
Complementary List 250 mg (as potassium salt)/5 ml
diethylcarbamazine Tablet: 50 mg; 100 mg Tablet: 250 mg (as potassium salt)
(dihydrogen citrate)
procaine benzylpenicillin Powder for injection:
suramin sodium Powder for injection: 1 g in vial 1 g (=1 million IU);
3 g (=3 million IU) in vial
6.1.3 Antischistosomals and antitrematode
medicine Complementary List
praziquantel Tablet: 600 mg ceftazidime Powder for injection: 250 mg
(as pentahydrate) in vial
triclabendazole Tablet: 250 mg
■ ceftriaxone Powder for injection: 250 mg,
Complementary List 1 g (as sodium salt) in vial
oxamniquine* Capsule: 250 mg imipenem* + Powder for injection:
cilastatin * 250 mg (as monohydrate) +
Oral liquid: 250 mg/5 ml 250 mg (as sodium salt);
500 mg (as monohydrate) +
* Oxamniquine is listed for use when praziquantel 500 mg (as sodium salt) in vial
treatment fails.
* Only listed for the treatment of life-threatening hos-
6.2 Antibacterials pital-based infection due to suspected or proven
multidrug-resistant infection.
6.2.1 Beta Lactam medicines

amoxicillin Capsule or tablet: 250 mg; 6.2.2 Other antibacterials

500 mg (anhydrous) azithromycin* Capsule: 250 mg or 500 mg
Powder for oral liquid: 125 mg
Oral liquid: 200 mg/5 ml
(anhydrous)/5 ml
* Only listed for single-dose treatment of genital
amoxicillin + Tablet: 500 mg + 125 mg Chlamydia trachomatis and of trachoma.
clavulanic acid

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WHO Drug Information Vol 21, No. 2, 2007
chloramphenicol Capsule: 250 mg
Oily suspension for injection:
0.5 g (as sodium succinate)/ml
in 2-ml ampoule
Oral liquid: 150 mg (as palmitate)/5 ml
Powder for injection: 1 g
(sodium succinate) in vial
■ ciprofloxacin* Tablet: 250 mg
(as hydrochloride)
* Final selection depends on indication for use.
doxycycline* Capsule or tablet:
100 mg (hydrochloride)
* Final selection depends on indication for use.
■ erythromycin Capsule or tablet: 250 mg
(as stearate or ethyl succinate)
Powder for injection: 500 mg
(as lactobionate) in vial
Powder for oral liquid: 125 mg
(as stearate or ethyl succinate)
■ gentamicin* Injection: 10 mg;
40 mg (as sulfate)/ml in 2-ml vial
* Final selection depends on indication for use.
■ metronidazole Injection: 500 mg in 100-ml vial
Oral liquid: 200 mg (as benzoate)/5 ml
Suppository: 500 mg; 1 g
Tablet: 200-500 mg
nitrofurantoin Tablet: 100 mg
spectinomycin Powder for injection: 2 g
(as hydrochloride) in vial
sulfamethoxazole + Injection: 80 mg + 16 mg/ml
trimethoprim in 5-ml and 10-ml ampoules
Oral liquid: 200 mg + 40 mg/5 ml
Tablet: 100 mg + 20 mg;
400 mg + 80 mg
trimethoprim Tablet: 100 mg; 200 mg
Complementary List
clindamycin Capsule: 150 mg
Injection: 150 mg
(as phosphate)/ml
15th Model List of Essential Medicines
sulfadiazine Injection: 250 mg
(sodium salt) in 4-ml ampoule
Tablet: 500 mg
vancomycin Powder for injection: 250 mg
(as hydrochloride) in vial
6.2.3 Antileprosy medicines
Medicines used in the treatment of leprosy should
never be used except in combination. Combination
therapy is essential to prevent the emergence of drug
resistance. Colour coded blister packs (MDT blister
packs) containing standard two medicine
(paucibacillary leprosy) or three medicine
(multibacillary leprosy) combinations for adult and
childhood leprosy should be used. MDT blister packs
can be supplied free of charge through WHO.
clofazimine Capsule: 50 mg; 100 mg
dapsone Tablet: 25 mg; 50 mg; 100 mg
rifampicin Capsule or tablet: 150 mg; 300 mg
6.2.4 Antituberculosis medicines
ethambutol Tablet: 100–400 mg (hydrochloride)
isoniazid Tablet: 100–300 mg
Tablet (scored): 50 mg
isoniazid + ethambutol Tablet: 150 mg + 400 mg
pyrazinamide Tablet: 400 mg
Tablet (dispersible): 150 mg
Tablet (scored): 150 mg
rifampicin Capsule or tablet: 150 mg; 300 mg
rifampicin + isoniazid Tablet: 60 mg + 30 mg;
150 mg + 75 mg; 300 mg + 150 mg
60 mg + 60 mg (For intermittent
use three times weekly)
150 mg + 150 mg (For intermittent
use three times weekly)
rifampicin + isoniazid + Tablet: 150 mg +
ethambutol 75 mg + 275 mg
rifampicin + isoniazid + Tablet: 60 mg +
pyrazinamide 30 mg + 150 mg;
150 mg + 75 mg + 400 mg
150 mg + 150 mg + 500 mg
(For intermittent use three times weekly)
rifampicin + isoniazid + Tablet: 150 mg + 75 mg +
pyrazinamide + ethambutol 400 mg + 275 mg
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streptomycin Powder for injection: 6.4.2 Antiretrovirals

1 g (as sulfate) in vial
Based on current evidence and experience of use,
Complementary List medicines in the following three classes of antiretro-
Reserve second-line drugs for the treatment of virals are included as essential medicines for treat-
multidrug-resistant tuberculosis (MDR-TB) should be ment and prevention of HIV (prevention of mother-
used in specialized centres adhering to WHO stand- to-child transmission and post exposure prophylaxis).
ards for TB control. The Committee emphasizes the importance of using
these products in accordance with global and national
amikacin Powder for injection: 1000 mg in vial guidelines. The Committee recommends and en-
dorses the use of fixed-dose combinations and the
ρ-aminosalicylic acid Granules: 4 g in sachet development of appropriate new fixed-dose combi-
Tablet: 500 mg nations, including modified dosage forms, non-refrig-
erated products and paediatric dosage forms with
capreomycin Powder for injection: 1000 mg in vial assured pharmaceutical quality.

cycloserine Capsule or tablet: 250 mg 6.4.2.1 Nucleoside/nucleotide reverse

transcriptase inhibitors
ethionamide Tablet: 125 mg; 250 mg
abacavir (ABC) Oral liquid: 100 mg
kanamycin Powder for injection: 1000 mg in vial (as sulfate)/5 m
ofloxacin* Tablet: 200 mg; 400 mg Tablet: 300 mg (as sulfate)
* Levofloxacin may be an alternative based on didanosine (ddI) Buffered powder for oral liquid:
availability and programme considerations. 100 mg; 167 mg; 250 mg packets
6.3 Antifungal medicines Capsule (unbuffered enteric-coated):
125 mg; 200 mg; 250 mg; 400 mg
clotrimazole Vaginal cream: 1%; 10%
Tablet (buffered chewable,
Vaginal tablet: 100 mg; 500 mg dispersible): 25 mg; 50 mg; 100 mg;
150 mg; 200 mg
■ fluconazole Capsule: 50 mg
emtricitabine (FTC)* Capsule: 200 mg
Injection: 2 mg/ml in vial
Oral liquid: 10 mg/ml
Oral liquid: 50 mg/5 ml
* 3TC is an acceptable alternative to FTC, based on
griseofulvin Capsule or tablet: 125 mg; 250 mg knowledge of the pharmacology, the resistance pat-
terns and clinical trials of antiretrovirals.
nystatin Lozenge: 100 000 IU
lamivudine (3TC) Tablet: 150 mg
Pessary: 100 000 IU
Oral liquid: 50 mg/5 ml
Tablet: 100 000 IU; 500 000 IU
stavudine (d4T) Capsule: 15 mg;
Complementary List 20 mg; 30 mg; 40 mg*
amphotericin B Powder for injection: * The Committee expects this dosage form to be
50 mg in vial reviewed for possible deletion at the next meeting.
flucytosine Capsule: 250 mg Powder for oral liquid: 5 mg/5 ml
Infusion: 2.5 g in 250 ml tenofovir Capsule: 300 mg (tenofovir
disoproxil fumarate – equivalent to
potassium iodide Saturated solution 245 mg tenofovir disoproxil)

6.4 Antiviral medicines zidovudine Capsule: 100 mg; 250 mg

6.4.1 Antiherpes medicines (ZDV or AZT) Oral liquid: 50 mg/5 ml

■ aciclovir Powder for injection: Solution for IV infusion

250 mg (as sodium salt) in vial injection: 10 mg/ml in 20-ml vial

Tablet: 200 mg Tablet: 300 mg

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WHO Drug Information Vol 21, No. 2, 2007 15th Model List of Essential Medicines

6.4.2.2 Non-nucleoside reverse transcriptase zidovudine + lamivudine + Tablet: 300 mg +

inhibitors nevirapine 150 mg + 200 mg

efavirenz (EFV or EFZ) Capsule: 50 mg; 6.4.3 Other antivirals

100 mg; 200 mg
ribavirin Injection for intravenous administration:
Oral liquid: 150 mg/5 ml 1000 mg and 800 mg in 10-ml
phosphate buffer solution
Tablet: 600 mg
Oral solid dosage forms: 200 mg;
nevirapine (NVP) Oral liquid: 50 mg/5 ml 400 mg; 600 mg
Tablet: 200 mg 6.5 Antiprotozoal medicines
6.4.2.3 Protease inhibitors 6.5.1 Antiamoebic and antigiardiasis medicines
Selection of protease inhibitor(s) from the Model List
will need to be determined by each country after con- diloxanide Tablet: 500 mg (furoate)
sideration of international and national treatment
guidelines and experience. Ritonavir is recommended ■ metronidazole Injection: 500 mg in 100-ml vial
for use in combination as a pharmacological booster,
and not as an antiretroviral in its own right. Oral liquid: 200 mg (as benzoate)/5 ml
Tablet: 200-500 mg
This section will be reviewed by the Committee as a
priority at its next meeting. It is expected that appli- 6.5.2 Antileishmaniasis medicines
cation for a heat stable tablet formulation containing
200/50 mg lopinavir + ritonavir will be submitted for ■ meglumine antimoniate Injection, 30%,
the next meeting. equivalent to approximately
8.1% antimony in 5-ml ampoule
indinavir (IDV) Capsule: 200 mg; 333 mg;
400 mg (as sulfate). paromomycin Solution for intramuscular injection:
lopinavir + Capsule: 133.3 mg + 33.3 mg 750 mg/2 ml (as sulfate)
ritonavir (LPV/r) Complementary List
Oral liquid: 400 mg + 100 mg/5 ml
amphotericin B Powder for injection:
nelfinavir (NFV) Oral powder: 50 mg/g 50 mg in vial
Tablet: 250 mg (as mesilate) pentamidine Powder for injection: 200 mg;
300 mg (isetionate) in vial
ritonavir Oral liquid: 400 mg/5 ml
6.5.3 Antimalarial medicines
Oral solid dosage form: 100 mg

saquinavir (SQV) Capsule: 200 mg

6.5.3.1 For curative treatment
Medicines for the treatment of P. falciparum malaria
FIXED-DOSE COMBINATIONS
cases should be used in combination. The list cur-
efavirenz + emtricitabine* Tablet: 600 mg + rently recommends combinations according to treat-
+ tenofovir 200 mg + 300 mg ment guidelines. The Committee recognizes that not
all of these FDCs exist and encourages their devel-
* 3TC is an acceptable alternative to FTC, based on opment and rigorous testing. The Committee also
knowledge of the pharmacology, the resistance pat- encourages development and testing of rectal dos-
terns and clinical trials of antiretrovirals. age formulations.

emtricitabine* + tenofovir Tablet: 200 mg + 300 mg amodiaquine* Tablet: 153 mg or 200 mg

(as hydrochloride)
* 3TC is an acceptable alternative to FTC, based on
knowledge of the pharmacology, the resistance pat- * To be used (a) in combination with artesunate 50
terns and clinical trials of antiretrovirals. mg OR (b) may be used alone for the treatment of
Plasmodium vivax, P.ovale and P.malariae
stavudine + lamivudine + Tablet: 30 mg + infections.
nevirapine 150 mg + 200 mg
artemether Oily injection: 80 mg/ml
zidovudine + lamivudine Tablet: 300 mg + 150 mg in 1-ml ampoule

For use in the management of severe malaria.

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artemether + Tablet: 20 mg + 120 mg mefloquine Tablet: 250 mg

lumefantrine* (as hydrochloride)

* Not recommended in the first trimester of pregnancy proguanil* Tablet: 100 mg (hydrochloride)
or in children below 5 kg.
* For use only in combination with chloroquine.
artesunate* Injection: ampoules,
containing 60 mg anhydrous 6.5.4 Antipneumocystosis and
artesunic acid with a separate antitoxoplasmosis medicines
ampoule of 5% sodium bicarbonate solution
pyrimethamine Tablet: 25 mg
For use in the management of severe malaria.
sulfamethoxazole + Injection: 80 mg + 16 mg/ml
Tablet: 50 mg trimethoprim in 5-ml ampoule; 80 mg +
16 mg/ml in 10-ml ampoule
* To be used in combination with either amodiaquine,
mefloquine or sulfadoxine + pyrimethamine. Complementary List
chloroquine Oral liquid: 50 mg (as pentamidine Tablet: 200 mg; 300 mg
phosphate or sulfate)/5 ml
6.5.5 Antitrypanosomal medicines
Tablet: 100 mg; 150 mg
(as phosphate or sulfate) 6.5.5.1 African trypanosomiasis
doxycycline* Capsule: 100 mg (as hydrochloride) Medicines for the treatment of 1st stage
African trypanosomiasis
Tablet (dispersible): 100 mg
(as monohydrate) pentamidine* Powder for injection: 200 mg
(pentamidine isetionate) in vial
* For use only in combination with quinine.
* To be used for the treatment of Trypansoma brucei
mefloquine* Tablet: 250 mg (as hydrochloride)
gambiense infection.
* To be used in combination with artesunate 50 mg suramin sodium* Powder for injection: 1 g in vial.
primaquine* Tablet: 7.5 mg; * To be used exclusively for the treatment of the ini-
15 mg (as diphosphate) tial phase of T. brucei rhodesiense infection.
* Only for use to achieve radical cure of P.vivax and Medicines for the treatment of
P.ovale infections, given for 14 days.
2nd stage African trypanosomiasis
quinine* Injection: 300 mg quinine
eflornithine Injection: 200 mg
hydrochloride/ml in 2-ml ampoule
(hydrochloride)/ml in 100-ml bottle
Tablet: 300 mg (quinine sulfate) melarsoprol Injection: 3.6% solution,
or 300 mg (quinine bisulfate) 5-ml ampoules (180 mg
* For use only in the management of severe malaria, of active compound)
and should be used in combination with doxycycline. 6.5.5.2 American trypanosomiasis
sulfadoxine + * Tablet: 500 mg + 25 mg
benznidazole Tablet: 100 mg
pyrimethamine
nifurtimox Tablet: 30 mg; 120 mg; 250 mg
* Only in combination with artesunate 50 mg
6.5.3.2 For prophylaxis 7. Antimigraine medicines
chloroquine* Oral liquid: 50 mg (as 7.1 For treatment of acute attack
phosphate or sulfate)/5 ml
acetylsalicylic acid Tablet: 300-500 mg
Tablet: 150 mg (as
phosphate or sulfate) paracetamol Tablet: 300-500 mg
* For use only in central American regions for P.vivax. 7.2 For prophylaxis
doxycycline Capsule or tablet: ■ propranolol Tablet: 20 mg; 40 mg
100 mg ( hydrochloride) (hydrochloride)

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8. Antineoplastic, immuno- mercaptopurine Tablet: 50 mg

suppressives and medicines methotrexate Powder for injection:
used in palliative care 50 mg (as sodium salt) in vial
Tablet: 2.5 mg (as sodium salt)
8.1 Immunosuppressive medicines
procarbazine Capsule: 50 mg (as hydrochloride)
Complementary List vinblastine Powder for injection:
10 mg (sulfate) in vial
azathioprine Powder for injection:
100 mg (as sodium salt) in vial vincristine Powder for injection:
1 mg; 5 mg (sulfate) in vial
Tablet: 50 mg
ciclosporin Capsule: 25 mg 8.3 Hormones and antihormones
Concentrate for injection: 50 mg/ml in Complementary List
1-ml ampoule for organ transplantation
dexamethasone Injection: 4 mg
8.2 Cytotoxic medicines dexamethasone phosphate (as
disodium salt) in 1-ml ampoule
This section is expected to be reviewed at the next
meeting. hydrocortisone Powder for injection: 100 mg
(as sodium succinate) in vial
Complementary List
■ prednisolone* Tablet: 5 mg; 25 mg
asparaginase Powder for injection:
10 000 IU in vial * There is no evidence for complete clinical similarity
between prednisolone and dexamethasone at high
bleomycin Powder for injection: doses.
15 mg (as sulfate) in vial
tamoxifen Tablet: 10 mg; 20 mg (as citrate)
calcium folinate Injection: 3 mg/ml
in 10-ml ampoule 8.4 Medicines used in palliative care
Tablet: 15 mg The WHO Expert Committee recognizes the impor-
tance of listing specific medicines in the Palliative
chlorambucil Tablet: 2 mg Care Section. Some medicines currently used in pal-
liative care are included in the relevant sections of
cisplatin Powder for injection: the Model List, according to their therapeutic use, e.g.
10 mg; 50 mg in vial analgesics. The Guidelines for Palliative Care that
were referenced in the previous list are in need of
cyclophosphamide Powder for injection: update. The Committee expects applications for medi-
500 mg in vial cines needed for palliative care to be submitted for
Tablet: 25 mg the next meeting.

cytarabine Powder for injection: 100 mg in vial 9. Antiparkinsonism medicines

dacarbazine Powder for injection: 100 mg in vial
dactinomycin Powder for injection:
500 micrograms in vial
daunorubicin Powder for injection:
50 mg (as hydrochloride)
doxorubicin Powder for injection: 10 mg;
50 mg (hydrochloride) in vial
etoposide Capsule: 100 mg
Injection: 20 mg/ml in 5-ml ampoule
fluorouracil Injection: 50 mg/ml
in 5-ml ampoule
biperiden Injection: 5 mg (lactate)
in 1-ml ampoule
Tablet: 2 mg (hydrochloride)
levodopa + ■ carbidopa Tablet: 100 mg + 10 mg;
250 mg + 25 mg
10. Medicinces affecting
the blood
10.1 Antianaemia medicines
ferrous salt Oral liquid: equivalent to 25 mg
iron (as sulfate)/ml

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Tablet: equivalent to 60 mg iron glyceryl trinitrate Tablet (sublingual): 500

micrograms
ferrous salt + Tablet equivalent to 60 mg iron +
folic acid 400 micrograms folic acid ■ isosorbide dinitrate Tablet (sublingual): 5 mg
(Nutritional supplement for use during pregnancy)
verapamil Tablet: 40 mg;
folic acid Tablet: 1 mg; 5 mg 80 mg (hydrochloride)

hydroxocobalamin Injection: 1 mg in 12.2 Antiarrhythmic medicines

1-ml ampoule
This subsection will be reviewed at the next meeting
10.2 Medicines affecting coagulation of the Expert Committee.

heparin sodium Injection: 1000 IU/ml; ■ atenolol Tablet: 50 mg; 100 mg

5000 IU/ml; 20,000
IU/ml in 1-ml ampoule digoxin Injection: 250 micrograms/
ml in 2-ml ampoule
phytomenadione Injection: 10 mg/ml
in 5-ml ampoule Oral liquid: 50 micrograms/ml

Tablet: 10 mg Tablet: 62.5 micrograms;

250 micrograms
protamine sulfate Injection: 10 mg/ml
in 5-ml ampoule epinephrine Injection: 100 micrograms/ml
(adrenaline) (as acid tartrate or hydrochloride)
■ warfarin Tablet: 1 mg; 2 mg; 5 mg (sodium salt) in 10-ml ampoule

lidocaine Injection: 20 mg (hydrochloride)/

11. Blood products and ml in 5-ml ampoule
plasma substitutes
verapamil Injection: 2.5 mg (hydrochloride)/
11.1 Plasma substitutes ml in 2-ml ampoule

■ dextran 70* Injectable solution: 6% Tablet: 40 mg; 80 mg (hydrochloride)

* Polygeline, injectable solution, 3.5% is considered Complementary List

as equivalent
■ procainamide Injection: 100 mg (hydro-
11.2 Plasma fractions for specific use chloride)/ml in 10-ml ampoule.
■ quinidine Tablet: 200 mg (sulfate)
All plasma fractions should comply with the WHO
Requirements for the Collection, Processing and 12.3 Antihypertensive medicines
Quality Control of Blood, Blood Components and
Plasma Derivatives (Revised 1992). (WHO Techni- ■ amlodipine Tablet: 5 mg
cal Report Series, No. 840, 1994, Annex 2).
■ atenolol Tablet: 50 mg; 100 mg
Complementary List
■ enalapril Tablet: 2.5 mg
human normal Intravenous administration:
immunoglobulin 5%, 10% protein solution hydralazine* Powder for injection:
20 mg (hydrochloride) in ampoule
Intramuscular administration:
16% protein solution Tablet: 25 mg, 50 mg (hydrochloride)

■ factor VIII concentrate Dried * Hydralazine is listed for use in the acute manage-
ment of severe pregnancy-induced hypertension only.
■ factor IX complex Dried Its use in the treatment of essential hypertension is
(coagulation factors, II, VII, not recommended in view of the availability of more
IX, X) concentrate evidence of efficacy and safety of other medicines.

■ hydrochlorothiazide Tablet (scored): 25 mg

12. Cardiovascular medicines
12.1 Antianginal medicines
■ atenolol
methyldopa* Tablet: 250 mg
* Methyldopa is listed for use in the management of
Tablet: 50 mg; 100 mg pregnancy-induced hypertension only. Its use in the

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treatment of essential hypertension is not recom- Complementary List

mended in view of the availability of more evidence
of efficacy and safety of other medicines. selenium sulfide Detergent-based
suspension: 2%
Complementary List
13.2 Anti-infective medicines
sodium nitroprusside Powder for infusion:
■ methylrosanilinium Aqueous solution: 0.5%
50 mg in ampoule
chloride (gentian violet)
12.4 Medicines used in heart failure Tincture: 0.5%
neomycin sulfate + Ointment: 5 mg neomycin
This subsection will be reviewed at the next meeting
■ bacitracin sulfate + 250 IU
of the Expert Committee.
bacitracin zinc/g
digoxin Injection: 250 micrograms/ potassium permanganate Aqueous solution:
ml in 2-ml ampoule 1:10 000
Oral liquid: 50 micrograms/ml silver sulfadiazine Cream: 1%, in 500-g container
Tablet: 62.5 micrograms; 250 micrograms 13.3 Anti-inflammatory and antipruritic
■ enalapril Tablet: 2.5 mg medicines
■ furosemide Injection: 10 mg/ml ■ betamethasone Ointment or cream:
in 2-ml ampoule 0.1% (as valerate)

Tablet: 40 mg ■ calamine lotion Lotion

■ hydrocortisone Ointment or cream:

■ hydrochlorothiazide Tablet (scored): 25 mg
1% (acetate)
Complementary List
13.4 Astringent medicines
dopamine Injection: 40 mg (hydrochloride)
in 5-ml vial aluminium diacetate Solution: 5%

12.5 Antithrombotic medicines 13.5 Medicines affecting skin

differentiation and proliferation
acetylsalicylic acid Tablet: 100 mg
benzoyl peroxide Lotion or cream: 5%
Complementary List
coal tar Solution: 5%
streptokinase Powder for injection:
1.5 million IU in vial dithranol Ointment: 0.1%-2%

12.6 Lipid-lowering agents fluorouracil Ointment: 5%

■ simvastatin* Tablet: 5 mg; 10 mg; ■ podophyllum resin Solution: 10-25%

20 mg; 40 mg
salicylic acid Solution: 5%
* For use in high-risk patients.
urea Ointment or cream: 10%

13. Dermatological medicines 13.6 Scabicides and pediculicides

(topical) ■ benzyl benzoate Lotion: 25%
13.1 Antifungal medicines permethrin Cream: 5%
benzoic acid + Ointment or cream: 6% + 3% Lotion: 1%
salicylic acid

■ miconazole Ointment or cream: 2% (nitrate)

14. Diagnostic agents
sodium thiosulfate Solution: 15% 14.1 Ophthalmic medicines
fluorescein Eye drops: 1% (sodium salt)

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15th Model List of Essential Medicines WHO Drug Information Vol 21, No. 2, 2007

■ tropicamide Eye drops: 0.5% Oral liquid: 75 mg/5 ml

14.2 Radiocontrast media Tablet: 150 mg (as hydrochloride)

magnesium Oral liquid: equivalent to

■ amidotrizoate Injection: 140-420 mg iodine
(as sodium or meglumine salt)/
ml in 20-ml ampoule
barium sulfate Aqueous suspension
■ iohexol Injection: 140-350 mg iodine/
ml in 5-ml; 10-ml; 20-ml ampoule
Complementary List
■ meglumine iotroxate Solution: 5-8 g iodine
in 100-250 ml
hydroxide 550 mg magnesium oxide/10 ml
17.2 Antiemetic medicines
metoclopramide Injection: 5 mg (hydrochloride)/
ml in 2-ml ampoule
Tablet: 10 mg (hydrochloride)
promethazine Injection: 25 mg (hydrochloride)/
ml in 2-ml ampoule
Oral liquid: 5 mg (hydrochloride)/5 ml

15. Disinfectants and antiseptics Tablet: 10 mg; 25 mg (hydrochloride)

15.1 Antiseptics 17.3 Anti-inflammatory medicines

■ sulfasalazine Retention enema
■ chlorhexidine Solution: 5% (digluconate)
for dilution Suppository: 500 mg
■ ethanol Solution: 70% (denatured) Tablet: 500 mg

■ polyvidone iodine Solution: 10% Complementary List

15.2 Disinfectants ■ hydrocortisone Retention enema

■ chlorine base Powder: (0.1% available Suppository: 25 mg (acetate)

compound chlorine) for solution
(■ only applies to hydrocortisone retention enema).
■ chloroxylenol Solution: 4.8%
17.4 Laxatives
glutaral Solution: 2%
■ senna Tablet: 7.5 mg (sennosides)
(or traditional dosage forms)
16. Diuretics
17.5 Medicines used in diarrhoea
amiloride Tablet: 5 mg (hydrochloride)
17.5.1 Oral rehydration
■ furosemide Injection: 10 mg/ml
in 2-ml ampoule oral rehydration salts*
Tablet: 40 mg glucose: 75 mEq
sodium: 75 mEq or mmol/l
■ hydrochlorothiazide Tablet (scored): 25 mg chloride: 65 mEq or mmol/l
mannitol Injectable solution: 10%; 20% potassium: 20 mEq or mmol/l
citrate: 10 mmol/l
spironolactone Tablet: 25 mg osmolarity: 245 mOsm/l

glucose: 13.5 g/l

17. Gastrointestinal medicines sodium chloride: 2.6 g/l
potassium chloride: 1.5 g/l
17.1 Antacids and other antiulcer trisodium citrate dihydrate+: 2.9 g/l
medicines
+ trisodium citrate dihydrate may be replaced by
aluminium hydroxide Oral liquid: 320 mg/5 ml sodium hydrogen carbonate (sodium bicarbonate)
Tablet: 500 mg 2.5 g/l. However, as the stability of this latter formu-
lation is very poor under tropical conditions, it is only
■ ranitidine Injection: 25 mg/ml in 2-ml ampoule recommended when manufactured for immediate
use.

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* In cases of cholera, a higher concentration of 18.3.3 Intrauterine devices

sodium may be required.
copper-containing device
17.5.2 Medicines for diarrhoea in children
18.3.4 Barrier methods
zinc sulfate* Oral liquid: in 10 mg
per unit dosage forms condoms
Tablet: in 10 mg diaphragms
per unit dosage forms
18.3.5 Implantable contraceptives
* In acute diarrhoea zinc sulfate should be used as
an adjunct to oral rehydration salts. levonorgestrel-releasing Two-rod levonorgestrel-
implant releasing implant, each
17.5.3 Antidiarrhoeal (symptomatic) medicines rod containing 75 mg of
in adults levonorgestrel (150 mg total)

codeine* Tablet: 30 mg (phosphate) 18.4 Estrogens

* The role of this item has been questioned and its
continued inclusion on the list will be reviewed at the
next meeting of the Expert Committee.
18. Hormones, other endocrine
medicines and contraceptives
■ ethinylestradiol* Tablet: 10 micrograms;
50 micrograms
* The public health relevance and/or comparative ef-
ficacy and/or safety of this item has been questioned
and its continued inclusion on the list will be reviewed
at the next meeting of the Expert Committee.

18.1 Adrenal hormones and synthetic 18.5 Insulins and other antidiabetic agents
substitutes glibenclamide Tablet: 2.5 mg; 5 mg
Addison’s disease is a rare condition; adrenal insulin injection Injection: 40 IU/ml in 10-ml vial;
hormones are already included in section 3. (soluble) 100 IU/ml in 10-ml vial

18.2 Androgens intermediate-acting Injection: 40 IU/ml in

insulin 10-ml vial; 100 IU/ml
Complementary List in 10-ml vial (as compound
insulin zinc suspension
testosterone Injection: 200 mg or isophane insulin)
(enantate) in 1-ml ampoule
metformin Tablet: 500 mg (hydrochloride)
18.3 Contraceptives
18.6 Ovulation inducers
18.3.1 Oral hormonal contraceptives
Complementary List
■ ethinylestradiol + Tablet: 30 micrograms +
■ levonorgestrel 150 micrograms clomifene Tablet: 50 mg (citrate)

■ ethinylestradiol + Tablet: 35 micrograms + 18.7 Progestogens

■ norethisterone 1.0 mg
norethisterone* Tablet: 5 mg
levonorgestrel Tablet: 30 micrograms;
750 micrograms (pack of two); * The public health relevance and/or comparative ef-
1.5 mg ficacy and/or safety of this item has been questioned
and its continued inclusion on the list will be reviewed
18.3.2 Injectable hormonal contraceptives at the next meeting of the Expert Committee.

medroxyprogesterone Depot injection: Complementary List

acetate 150 mg/ml in 1-ml vial
medroxyprogesterone acetate + Injection:
estradiol cypionate 25 mg + 5 mg
norethisterone enantate Oily solution: 200 mg/ml
in 1-ml ampoule
medroxyprogesterone acetate* Tablet: 5 mg
* The public health relevance and/or comparative ef-
ficacy and/or safety of this item has been questioned
and its continued inclusion on the list will be reviewed
at the next meeting of the Expert Committee.

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18.8 Thyroid hormones and antithyroid All vaccines should comply with the WHO Require-
medicines ments for Biological Substances.

BCG vaccine
levothyroxine Tablet: 50 micrograms;
100 micrograms (sodium salt) cholera vaccine
potassium iodide Tablet: 60 mg diphtheria vaccine
■ propylthiouracil Tablet: 50 mg hepatitis A vaccine

19. Immunologicals hepatitis B vaccine

Haemophilus influenzae type b vaccine
19.1 Diagnostic agents
influenza vaccine
All tuberculins should comply with the WHO Require-
ments for Tuberculins (Revised 1985). WHO Expert Japanese encephalitis vaccine
Committee on Biological Standardization. Thirty-sixth
report. (WHO Technical Report Series, No. 745, 1987, measles vaccine
Annex 1).
meningococcal meningitis vaccine
tuberculin, purified protein Injection
derivative (PPD) mumps vaccine

19.2 Sera and immunoglobulins pertussis vaccine

pneumococcal vaccine
All plasma fractions should comply with the WHO
Requirements for the Collection, Processing and poliomyelitis vaccine
Quality Control of Blood, Blood Components and
Plasma Derivatives (Revised 1992). WHO Expert rabies vaccine
Committee on Biological Standardization. Forty-third
report. (WHO Technical Report Series, No. 840, 1994, rotavirus vaccine
Annex 2).
rubella vaccine
anti-D immunoglobulin Injection: 250 micrograms
tetanus vaccine
(human) in single-dose vial
typhoid vaccine
antitetanus immunoglobulin Injection: 500 IU
(human) in vial varicella vaccine
antivenom immunoglobulin* Injection yellow fever vaccine
* Exact type to be defined locally.
20. Muscle relaxants
diphtheria antitoxin Injection: 10 000 IU; (peripherally acting) and
20 000 IU in vial
cholinesterase inhibitors
■ rabies immunoglobulin Injection: 150 IU/
ml in vial ■ alcuronium Injection: 5 mg (chloride)/
ml in 2-ml ampoule
19.3 Vaccines
neostigmine Injection: 500 micrograms
Selection of vaccines from the Model List will need to in 1-ml ampoule; 2.5 mg
be determined by each country after consideration (metilsulfate) in 1-ml ampoule
of international recommendations, epidemiology and
national priorities. The list below details the vaccines Tablet: 15 mg (bromide)
for which there is either a recommendation from the
Strategic Advisory Group of Experts on Immuniza- suxamethonium Injection: 50 mg (chloride)/
tion (SAGE) (http://www.who.int/immunization/ ml in 2-ml ampoule
sage_conclusions/en/index.html) and/or a WHO po- Powder for injection (chloride), in vial
sition paper (http://www.who.int/immunization/docu-
ments/positionpapers/en/index.html). This site will be Complementary List
updated as new position papers are published and
contains the most recent information and recommen- pyridostigmine Injection: 1 mg in 1-ml ampoule
dations.

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Tablet: 60 mg (bromide) mifepristone* – Tablet 200 mg –

misoprostol * tablet 200 micrograms
■ vecuronium Powder for injection:
10 mg (bromide) in vial * Requires close medical supervision.

21. Ophthalmological Where permitted under national law

and where culturally acceptable.
preparations
This section will be reviewed at the next meeting of 22.2 Antioxytocics (tocolytics)
the Expert Committee.
nifedipine Immediate release capsule: 10 mg
21.1 Anti-infective agents
23. Peritoneal dialysis solution
aciclovir Ointment: 3% W/W
Complementary List
■ gentamicin* Solution (eye drops): 0.3% (sulfate)
intraperitoneal dialysis solution Parenteral
* Final selection depends on indication for use. (of appropriate composition) solution
■ tetracycline Eye ointment: 1% (hydrochloride)
24. Psychotherapeutic
21.2 Anti-inflammatory agents medicines
■ prednisolone Solution (eye drops):
0.5% (sodium phosphate) 24.1 Medicines used in psychotic
disorders
21.3 Local anaesthetics
■ chlorpromazine Injection: 25 mg (hydro
■ tetracaine Solution (eye drops): chloride)/ml in 2-ml ampoule
0.5% (hydrochloride)
Oral liquid: 25 mg (hydrochloride)/5 ml
21.4 Miotics and antiglaucoma medicines Tablet: 100 mg (hydrochloride)
acetazolamide Tablet: 250 mg
■ fluphenazine Injection: 25 mg (decanoate
■ pilocarpine Solution (eye drops): 2%; or enantate) in 1-ml ampoule
4% (hydrochloride or nitrate)
■ haloperidol Injection: 5 mg in 1-ml ampoule
■ timolol Solution (eye drops): 0.25%;
Tablet: 2 mg; 5 mg
0.5% (as maleate)

21.5 Mydriatics 24.2 Medicines used in mood disorders

24.2.1 Medicines used in depressive disorders
atropine Solution (eye drops): 0.1%;
0.5%, 1% (sulfate) ■ amitriptyline Tablet: 25 mg (hydrochloride)
Complementary List
fluoxetine Capsule or tablet: 20 mg
epinephrine Solution (eye drops): 2% (present as hydrochloride)
(adrenaline) (as hydrochloride)
24.2.2 Medicines used in bipolar disorders
22. Oxytocics and antioxytocics carbamazepine Tablet (scored): 100 mg; 200 mg

22.1 Oxytocics lithium carbonate Capsule or tablet: 300 mg

■ ergometrine Injection: 200 micrograms valproic acid Tablet (enteric-coated): 200 mg;
(hydrogen maleate) in 1-ml ampoule 500 mg (sodium valproate)
oxytocin Injection: 10 IU in 1-ml ampoule 24.3 Medicines used in generalized
Complementary List anxiety and sleep disorders
misoprostol Vaginal tablet: 25 micrograms ■ diazepam Tablet (scored): 2 mg; 5 mg

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24.4 Medicines used for obsessive 26. Solutions correcting water,

compulsive disorders and panic attacks electrolyte and acid-base
clomipramine Capsule: 10 mg; 25 mg disturbances
(hydrochloride)
26.1 Oral
24.5 Medicines used in substance
oral rehydration salts See section 17.5.1
dependence programmes
potassium chloride Powder for solution
Complementary List
■ methadone* Concentrate for oral liquid: 26.2 Parenteral
5 mg/ml; 10 mg/ml (hydrochloride)
glucose Injectable solution: 5%;
Oral liquid: 5 mg/5 ml; 10 mg/5 ml 10% isotonic; 50% hypertonic

* The square box is added to include buprenorphine.
The medicines should only be used within an estab-
lished support programme.
25. Medicines acting on the
respiratory tract
25.1 Antiasthmatic and medicines for
chronic obstructive pulmonary disease
■ beclometasone Inhalation (aerosol):
50 micrograms per dose
(dipropionate); 250 micrograms
(dipropionate) per dose
epinephrine Injection: 1 mg (as hydrochloride
(adrenaline) or hydrogen tartrate) in
1-ml ampoule
ipratropium bromide Inhalation (aerosol): 20
micrograms/metered dose
■ salbutamol Inhalation (aerosol): 100 micro-
grams (as sulfate) per dose
Injection: 50 micrograms (as
sulfate)/ml in 5-ml ampoule
glucose with Injectable solution: 4% glucose,
sodium chloride 0.18% sodium chloride
(equivalent to Na+ 30 mmol/l,
Cl- 30 mmol/l)
potassium chloride Solution: 11.2% in
20-ml ampoule
(equivalent to K+ 1.5 mmol/ml,
Cl- 1.5 mmol/ml)
sodium chloride Injectable solution: 0.9% isotonic
(equivalent to Na+ 154 mmol/l,
Cl- 154 mmol/l
sodium hydrogen Injectable solution:
carbonate 1.4% isotonic (equivalent to
Na+ 167 mmol/l, HCO3- 167 mmol/l)
Solution: 8.4% in 10-ml
ampoule (equivalent to
+
Na 1000 mmol/l, HCO3-1000 mmol/l)
■ sodium lactate, Injectable solution
compound solution
26.3 Miscellaneous
water for injection 2-ml; 5-ml; 10-ml ampoules

Oral liquid: 2 mg/5 ml 27. Vitamins and minerals

Respirator solution for use in nebulizers: ascorbic acid Tablet: 50 mg
5 mg (as sulfate)/ml
■ ergocalciferol Capsule or tablet:
Tablet: 2 mg; 4 mg (as sulfate) 1.25 mg (50 000 IU)

25.2 Other medicines acting on the Oral liquid: 250 micrograms/

respiratory tract ml (10 000 IU/ml)
iodine Capsule: 200 mg
caffeine citrate Injection: 20 mg/ml (equivalent to
10 mg caffeine base/ml)
Iodized oil: 1 ml (480 mg iodine);
Oral liquid: 20 mg/ml (equivalent to 0.5 ml (240 mg iodine) in ampoule
10 mg caffeine base/ml) (oral or injectable); 0.57 ml (308 mg iodine)
in dispenser bottle

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■ nicotinamide Tablet: 50 mg riboflavin Tablet: 5 mg

pyridoxine Tablet: 25 mg (hydrochloride) sodium fluoride In any appropriate
topical formulation
retinol Capsule: 50 000 IU; 100 000 IU;
200 000 IU (as palmitate) thiamine Tablet: 50 mg (hydrochloride)
Oral oily solution: 100 000 IU Complementary List
(as palmitate)/ml in multidose dispenser
calcium gluconate Injection: 100 mg/ml
Tablet (sugar-coated): 10 000 IU (as palmitate) in 10-ml ampoule
Water-miscible injection: 100 000 IU
(as palmitate) in 2-ml ampoule

111

Regulatory Action and News
Tegaserod: marketing
suspension
Canada — Marketing and sales of
tegaserod hydrogen maleate (Zelnorm®)
tablets have been suspended in Canada
to permit further evaluation of important
safety information.
Zelnorm® is a serotonin 5-HT4 receptor
partial agonist indicated for the sympto-
matic treatment of irritable bowel syn-
drome with constipation in female pa-
tients whose main symptoms are consti-
pation and abdominal pain and/or dis-
comfort and for the treatment of chronic
idiopathic constipation in patients under
65 years of age.
A recent retrospective analysis of pooled
clinical trial data showed that the inci-
dence of cardiovascular ischemic events
(1) in patients taking Zelnorm® was
higher than in those taking placebo:
Canadian pharmacists and distributors
have been requested to return the prod-
uct to the company. Patients should
discontinue treatment and contact their
physician for advice about alternative
therapies.
Reference: Communication from Novartis
Pharmaceuticals Canada Inc. 30 March 2007
posted by Medeffect at http://www.hc-sc.gc.ca
United States of America — The Food
and Drug Administration (FDA) has
informed patients and health care prof-
essionals that tegaserod maleate
(Zelnorm®) will no longer be marketed. A
new safety analysis has found a higher
chance of heart attack, stroke, and
worsening heart chest pain in patients
treated with tegaserod compared to
112
WHO Drug Information Vol 21, No. 2, 2007
placebo. Zelnorm® is a prescription
medication approved for short term
treatment of women with irritable bowel
syndrome with constipation and for
patients younger than 65 years with
chronic constipation.
Patients should contact their physician to
discuss alternative treatments for their
condition. Physicians should work with
their patients and transition them to other
therapies as appropriate to their symp-
toms and need.
Thirteen patients treated with Zelnorm®
(0.1%) had serious and life-threatening
cardiovascular side effects; among these,
four patients had a heart attack (one
died), six had a type of severe heart chest
pain which can quickly turn into a heart
attack, and three had a stroke.
The FDA has indicated a willingness to
consider limited re-introduction of
Zelnorm® at a later date if a population of
patients can be identified in whom the
benefits of the drug outweigh the risks.
However, before FDA makes a decision
about limited re-introduction, any pro-
posed plan would be discussed at a
public advisory committee meeting.
Reference: FDA Public Health Advisory, 30
March 2007
Pergolide: voluntary
withdrawal of products
United States of America — The Food
and Drug Administration (FDA) has
announced that manufacturers of
pergolide drug products, used to treat
Parkinson disease, will voluntarily remove
these drugs from the market because of
the risk of serious damage to patients’
heart valves. The products being with-
WHO Drug Information Vol 21, No. 2, 2007
drawn are Permax®, the trade name for
pergolide, and two generic versions
Two new studies showed that patients
with Parkinson disease who were treated
with pergolide had an increased chance
of serious damage to their heart valves
when compared to patients who did not
receive the drug. Pergolide is a dopamine
agonist used with levodopa and carbi-
dopa to manage the signs and symptoms
of Parkinson disease.
Healthcare professionals who prescribe
pergolide should consider the following:
• If continued treatment is necessary,
another dopamine agonist should be
substituted for pergolide. There are
other dopamine agonists approved for
the treatment of Parkinson disease that
are not associated with heart valve
damage. Published transition regimens
describe the conversion from one DA to
another.
• If treatment with a dopamine agonist is
to be discontinued, pergolide should not
be stopped abruptly, because rapid
discontinuation of all dopamine agonist
therapies can be dangerous. Instead,
gradually decrease the dose of
pergolide.
• Patients who will be taken off pergolide
should be told that other effective
options for treatment exist, including
three other dopamine agonists that are
not associated with damage to heart
valves.
One of the drugs included in the recent
studies showing increased chance of
heart valve problems is cabergoline
(Dostinex®), another dopamine agonist.
This drug is approved in the US for the
treatment of hyperproteinaemia disorders.
Dostinex® is not approved in the US for
the treatment of Parkinson disease. For
Regulatory Action and News
hyperproteinaemia disorders, a consider-
ably lower dose of Dostinex® is used.
Reference: FDA News, P07-54 and Public
Health Advisory, 29 March 2007 at http://
www.fda.gov
Aliskiren approved for
hypertension
United States of America — The Food
and Drug Administration (FDA) has
announced the approval of aliskiren
(Tekturna®) tablets for the treatment of
hypertension. Aliskiren acts by inhibiting
renin.
Effectiveness was demonstrated in six
placebo-controlled eight-week clinical
trials, which studied over 2000 patients
with mild to moderate hypertension. The
effect was maintained for up to one year.
When used in combination with hydro-
chlorothiazide, further reductions in blood
pressure were achieved.
Aliskiren was effective across all demo-
graphic subgroups, but African American
patients tended to have smaller reduc-
tions in blood pressure than Caucasians
and Asians, as is generally true for drugs
that affect the renin-angiotensin system.
Side effects were usually mild and brief.
Diarrhoea was reported by approximately
2 percent of patients on the higher of the
two approved doses, compared with
approximately 1 percent on placebo.
Rarely, patients developed an allergic
reaction with swelling of the face, lips or
tongue and difficulty breathing. This has
been seen with other drugs for high blood
pressure that act directly on the renin-
angiotensin system.
Aliskiren and other drugs that act directly
on the renin-angiotensin system should
not be used during pregnancy.
Reference: FDA News, P07-38. 6 March 2007
at http://www.fda.gov
113
Regulatory Action and News
Lapatinib approved for
advanced breast cancer
United States of America —The Food
and Drug Administration (FDA) has
approved lapatinib (Tykerb ®), a targeted
anti-cancer treatment to be used in
combination with capectabine (Xeloda®)
for patients with advanced, metastatic
breast cancer that is HER2 positive. The
combination treatment is indicated for
women who have received prior therapy
with other cancer drugs, including an
anthracycline, a taxane, and trastuzumab.
According to the American Cancer
Society, about 180 000 new cases of
breast cancer are diagnosed each year.
Lapatinib is a kinase inhibitor unlike, for
example, trastuzumab — a monoclonal
antibody, which is a large protein mol-
ecule that targets the part of the HER2
protein on the outside of the cell. Be-
cause of this difference in mechanism of
action, Tykerb® works in some HER2
positive breast cancers that are no longer
benefiting from trastuzumab.
Commonly reported side effects included
diarrhoea, nausea, vomiting, rash and
hand-foot syndrome which may include
numbness, tingling, redness, swelling and
discomfort of hands and feet. Generally
reversible decreases in heart function
have also been reported in a small
percentage of patients.
Reference: FDA News, P07-44, 13 March
2007 at http://www.fda.gov
Adalimumab approved
for Crohn disease
United States of America — The Food
and Drug Administration (FDA) has
approved adalimumab (Humira®) to treat
adult patients with moderate to severe
Crohn disease. Adalimumab is a human-
derived, genetically-engineered mono-
clonal antibody to reduce excessive
114
WHO Drug Information Vol 21, No. 2, 2007
levels of human tumour necrosis factor
alpha, which plays an important role in
abnormal inflammatory and immune
responses. The labelling includes a
boxed warning about potential serious
adverse events. Adalimumab has been
studied in 1478 patients with Crohn
disease in four clinical trials comparing
the drug to a placebo and two longer term
extension studies.
Use of this product has been associated
with serious, sometimes fatal, infections,
including cases of tuberculosis, opportun-
istic infections, and sepsis. Before initiat-
ing adalimumab treatment, patients
should be evaluated for tuberculosis risk
factors and tested for latent tuberculosis
infection. Other serious adverse events
reported by adalimumab users include
lymphoma. The most frequent adverse
events included upper respiratory infec-
tions, sinusitis, and nausea.
Humira® was previously approved for the
treatment of three autoimmune diseases:
rheumatoid arthritis, psoriatic arthritis,
and ankylosing spondylitis.
Reference: FDA News, P07-30. 27 February
2007 at http://www.fda.gov
Rapid test for meningitis
cleared for marketing
United States of America — The Food
and Drug Administration (FDA) has
cleared for marketing a test that uses
molecular biology to quickly detect the
presence of viral meningitis.
The Xpert EV® test, when used in combi-
nation with other laboratory tests, will help
physicians distinguish between viral and
bacterial meningitis.
Meningitis is diagnosed by testing the
fluid obtained from a patient during a
spinal tap. Typically, diagnostic tests for
meningitis can take up to a week to get
WHO Drug Information Vol 21, No. 2, 2007
results. But results from the Xpert EV test
are available in two and one-half hours.
The accuracy of the Xpert EV® test was
confirmed in a multi-site study at six
institutions. A total of 255 patient samples
were tested and demonstrated that 96
percent of patients who tested positive
did have viral meningitis, and that 97
percent of patients who tested negative
did not have viral meningitis.
Reference: FDA News, P07-46, 16 March
2007 at http://www.fda.gov
Eculizumab approved for
paroxysmal nocturnal
haemoglobinuria
United States of America —The Food
and Drug Administration (FDA) has
approved eculizumab (Soliris®), the first
product for the treatment of paroxysmal
nocturnal haemoglobinuria (PNH), a rare
type of blood disorder that can lead to
disability and premature death.
PNH, which usually develops in adults, is
a disease characterized by red blood
cells that develop abnormally. Once the
abnormal cells are present in the blood-
stream, naturally occurring proteins
Regulatory Action and News
designed to destroy bacteria and other
infection-causing organisms break these
cells down. This leads to abnormally
darkened urine and, more importantly,
causes anaemia. Depending upon the
severity of the disorder, patients with PNH
may have pain, fatigue and debilitating
weakness, the need for frequent blood
transfusions, blood clots, and life-threat-
ening or fatal strokes, heart attacks and
intestinal disease.
Eculizumab does not cure PNH, but
treats the breakdown of red blood cells,
the most common characteristic of PNH.
Eculizumab blockade of the body’s
natural immune system increases the
patient’s susceptibility to certain serious
infections, particularly meningococcal
infections. Serious meningococcal infec-
tion was the most important adverse
reaction experienced by patients in
clinical studies. Because of the high risk
for serious meningococcal infections, all
196 PNH patients in the clinical studies
were vaccinated with a meningococcal
vaccine; two of them developed meningo-
coccal sepsis.
Reference: FDA News, P07-47, 16 March
2007 at http://www.fda.gov
115

Access to Medicines
Neglected tropical diseases
One sixth of the world’s population suffer
from one or more neglected tropical
diseases such as Buruli ulcer, cholera,
cysticercosis, dracunculiasis (guinea-
worm disease), foodborne trematode
infections, such as fascioliasis, hydatido-
sis, leishmaniasis, lymphatic filariasis,
onchocerciasis, schistosomiasis, soil-
transmitted helminthiasis, trachoma and
trypanosomiasis, although there are other
estimates that suggest the number could
be much higher.
Several of these diseases are vector-
borne. Populations most affected are
often the poorest and most vulnerable
and are in tropical and subtropical areas
of the world. Some diseases affect in-
dividuals throughout their lives, causing a
high degree of morbidity and physical
disability and, in certain cases, gross
disfigurement. Others are acute infec-
tions, with transient, severe and some-
times fatal outcomes.
For a large group of these diseases –
mainly helminthic infections – effective,
inexpensive or donated drugs are avail-
able for their prevention and control.
However, there is second group which
requires systematic case-finding and
management at an early stage. Simple
diagnostic tools and safe and effective
treatment regimens still need to be
developed for some of these diseases.
For others, vector control is available, as
in the case of Chagas disease.
Increased awareness and advocacy are
needed to draw attention to the realistic
prospect of reducing the negative impact
of neglected tropical diseases on the
116
WHO Drug Information Vol 21, No. 2, 2007
health and social and economic well-
being of affected communities.
Reference: WHO Department of Control of
Neglected Tropical Diseases at http://
www.who.int/neglected_diseases/en/
index.html
Open access database
for neglected medicines
development
An international network of researchers
has announced the release of a new
web-based resource designed to facilitate
the development of medicines to fight
infectious diseases afflicting the
developing world. The Drug Target
Prioritization Database is available at
http://TDRtargets.org.
The database is described as a compre-
hensive set of information pertinent to
drug target discovery, for a diverse
array of parasitic and bacterial diseases.
The Drug Target Prioritization Network
was established in 2005 by the Special
Programme for Research and Training in
Tropical diseases (TDR) of WHO and
includes a global team of academic
laboratories, research centres and
industry scientists, focusing on the
pathogens responsible for malaria,
tuberculosis, African sleeping sickness,
leishmaniasis, Chagas disease and
worm infections such as schistosomiasis
and filariasis — all of which are
in desperate need of new treatments.
Together, these diseases are responsible
for billions of infections in the developing
world and more than six million deaths
per year.
WHO Drug Information Vol 21, No. 2, 2007
New avenues for drug discovery
The database is unique in that it allows
any researcher — in both developed and
developing countries — to have access to
information on the complete genome
sequences for organisms responsible for
five tropical diseases, with more antici-
pated for the parasitic worms known as
helminths. Pharmaceutical firms have
extensive libraries of chemicals that might
act against the disease pathogens. The
missing step, which this initiative takes, is
to make available a list of proposed and
validated drug targets, in addition to
allowing users to define their own search
criteria. This resource should expedite the
time-consuming and high-risk early
stages of drug development.
The TDRtargets.org web site combines
available genomic and bioinformatic
data for each priority organism with
automatically extracted and manually
curated information from the research
Access to Medicines
literature and other databases relevant to
each putative drug target. The network
has invested substantial effort in annota-
tion to assist scientists in the identification
of high-value drug targets. The database
also permits comments from experts in
the field.
User-defined weightings permit potential
drug targets to be ranked according to
their desirability, providing prioritized,
customized lists. While this network was
developed to facilitate drug target identifi-
cation, it is also useful for the identifica-
tion of vaccine and diagnostic targets as
well, and could spur fundamental re-
search into areas such as target valida-
tion, assay development, biomarkers and
drug resistance.
Reference: Special Programme for Research
and Training in Tropical diseases (TDR) at
http://TDRtargets.org
117
 WHO Drug Information Vol 21, No. 2, 2007

Consultation Document
International Pharmacopoeia

Artemether and lumefantrine capsules

Draft proposal for the International Pharmacopoeia (March 2007). Please

address any comments to Quality Assurance and Safety: Medicines, Medi-
cines Policy and Standards, World Health Organization, 1211 Geneva 27,
Switzerland. Fax: ++41 22 791 4730 or e-mail to rabhouansm@who.int

Category. Antimalarial.

Storage. Artemether and Lumefantrine capsules should be kept in a well-closed

container, protected from light.

Additional information. Strength in the current WHO Model List of Essential Medi-
cines: 20 mg Artemether and 120 mg Lumefantrine.

[Note from the Secretariat: Artemether and Lumefantrine capsules are not included in
the current WHO Model list of essential medicines, only tablets of above strength.]

REQUIREMENTS

Complies with the monograph for “Capsules”.

Artemether and Lumefantrine capsules contain Artemether and Lumefantrine. They

contain not less than 90.0% and not more than 110.0% of the amounts of artemether
(C16H26O5) and lumefantrine (C30H32Cl3NO) stated on the label.

Identity tests

A Carry out test A.1 or, where UV detection is not available, test A.2.

A.1. Carry out the test as described under 1.14.1 Thin-layer chromatography, using
silica gel R6 as the coating substance and a mixture of 40 volumes of light
petroleum R1, 10 volumes of ethyl acetate R and 5 volumes of glacial acetic acid
R as the mobile phase. Apply separately to the plate 10 µl of each of the following
2 solutions in acetone R. For solution (A) shake a quantity of the contents of the
capsules equivalent to about 10 mg Artemether (about 60 mg Lumefantrine) for 5
minutes with 10 ml, filter, and use the clear filtrate. For solution (B) use 1 mg
artemether RS and 6 mg lumefantrine RS per ml. After removing the plate from
the chromatographic chamber, allow it to dry exhaustively in air or in a current of
cool air.

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WHO Drug Information Vol 21, No. 2, 2007 International Pharmacopoeia

(i) Examine the chromatogram in ultraviolet light (254 nm).

The principal spot obtained with solution A corresponds in position, appearance,

and intensity to that obtained with solution B (identifying Lumefantrine).

(ii) Spray the plate with sulfuric acid/methanol TS. Heat the plate for 10 minutes at
140 ˚C. Examine the chromatogram in daylight.

The principal spot obtained with solution A corresponds in position, appearance,

and intensity to that obtained with solution B (identifying Artemether).

A.2. Carry out the test as described under 1.14.1 Thin-layer chromatography, using
silica gel R5 as the coating substance and a mixture of 40 volumes of light
petroleum R1, 10 volumes of ethyl acetate R and 5 volumes of glacial acetic acid
R as the mobile phase. Apply separately to the plate 10 µl of each of the following
2 solutions in acetone R. For solution (A) shake a quantity of the contents of the
capsules equivalent to about 10 mg Artemether (about 60 mg Lumefantrine) for 5
minutes with 10 ml, filter, and use the clear filtrate. For solution (B) use 1 mg
artemether RS and 6 mg lumefantrine RS per ml. After removing the plate from
the chromatographic chamber, allow it to dry exhaustively in air or in a current of
cool air. Spray with sulfuric acid/methanol TS. Heat the plate for 10 minutes at
140˚C, allow it to cool and expose to iodine vapours for 20 minutes. Examine the
chromatogram immediately in daylight.

The principal spots obtained with solution A corresponds in position, appearance,

and intensity to those obtained with solution B.

B. See the test described below under Assay. The retention times of the two principal
peaks in the chromatogram obtained with solution (1) are similar to those in the chro-
matogram obtained with solution (2).

Artemether-related substances. Protect samples from light, also during chromato-

graphy.

Carry out the test as described under 1.14.1 Thin-layer chromatography, using silica
gel R5 as the coating substance and a mixture of 40 volumes of light petroleum R1, 10
volumes of ethyl acetate R and 5 volumes of glacial acetic acid R as the mobile phase.

Prepare the following solutions in the solvent consisting of 1 volume of purified water
and 1 volume of acetonitrile R. For solution (1), weigh and mix the contents of 20
capsules. To a quantity of the powder containing 100 mg of artemether add 20 ml of
the solvent, sonicate for 15 minutes and centrifuge. Filter a portion of the supernatant
through a 0.45 µm filter, discarding the first few ml of the filtered solution. For solution
(2) dissolve 2 mg of each of artemether RS, dihydroartemisinin (artenimol RS) and á-
artemether RS in 20 ml of the solvent. For solution (3) dilute 2.0 ml of solution (2) to 20
ml with the solvent. For solution (4) dilute 3.0 ml of solution (2) to 20 ml with the
solvent. For solution (5) dilute 5.0 ml of solution (2) to 20 ml with the solvent. For
solution (6) dilute 1.0 ml of solution (2) to 2 ml with the solvent. For solution (7) dilute
3.0 ml of solution (2) to 4 ml with the solvent.

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International Pharmacopoeia WHO Drug Information Vol 21, No. 2, 2007

Apply separately to the plate 20 µl of each of the solution (1), (3), (4), (5), (6) and (7).
After application allow the spots to dry for 15 minutes in a current of cool air. Develop
over a path of 12 cm. After removing the plate from the chromatographic chamber,
allow it to dry exhaustively in air or in a current of cool air. Dip the plate in sulfuric acid/
methanol TS. Heat the plate for 10 minutes at 140 ˚C. Examine the chromatogram in
daylight.

Artemether and related substances have the following Rf values: impurity A about
0.25; dihydroartemisinin about 0.3; impurity B about 0.35; α-artemether about 0.4;
artemether about 0.55.

In the chromatogram obtained with solution (1):

–any spot corresponding in Rf value to impurity A is not more intense than the
spot corresponding to artemether obtained with solution (7) (1.5%);

–any spot corresponding in Rf value to dihydroartemisinin is not more intense

than the spot corresponding to dihydroartemisinin obtained with solution (6)
(1.0%);

–any spot corresponding in Rf value to impurity B is not more intense than the
spot corresponding to artemether obtained with solution (5) (0.5%);

–any spot corresponding in Rf value to á-artemether is not more intense than the
spot corresponding to á-artemether obtained with solution (4) (0.3%);

–the spot of any other impurity is not more intense than the spot corresponding
to artemether obtained with solution (3) (0.2%). Disregard any spot remaining at
the point of application.

Assay. Carry out the test as described under 1.14.4 High-performance liquid chroma-
tography, using a stainless steel column (15 cm x 3.9 mm) packed with particles of
silica gel, the surface of which has been modified with chemically bonded
octadecylsilyl groups (5 ìm) (1 Symmetry is suitable.)

Use the following conditions for gradient elution:

Mobile phase A: 700 volumes of ion pair reagent and 300 volumes of
acetonitrile R.

Mobile phase B: 300 volumes of ion pair reagent and 700 volumes of
acetonitrile R.

Prepare the ion pair reagent by dissolving 5.65 g of sodium hexanesulfonate R and
2.75 g of sodium dihydrogen phosphate R in about 900 ml of purified water. Adjust the
pH to 2.3 using phosphoric acid (~105 g/l) TS, dilute to 1000 ml and filter through a
0.45 µm filter.

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WHO Drug Information Vol 21, No. 2, 2007 International Pharmacopoeia

Time Mobile phase A Mobile phase B Comments

(min) (% v/v) (% v/v)

0–28 60 40 Isocratic
28–29 60 to 0 40 to 100 Linear gradient
29–45 0 100 Isocratic
45–46 0 to 60 100 to 40 Linear gradient
46–55 60 40 Isocratic re-equilibration

Prepare the following solutions in the solvent which is obtained by mixing 200 ml of
ion pair reagent, 60 ml of purified water and 200 ml of 1-propanol R and diluting to
1000 ml with acetonitrile R. For solution (1), weigh and mix the contents of 20 cap-
sules. Transfer a quantity of the powder containing about 20 mg of artemether (about
120 mg of lumefantrine), accurately weighed, to a 100 ml volumetric flask. Add ap-
proximately 85 ml of the solvent, sonicate for 20 minutes, allow to cool to room tem-
perature and dilute to volume with the solvent. Filter through a 0.45 µm filter, discard-
ing the first few ml of the filtered solution. For solution (2), accurately weigh 20 mg
artemether RS and 120 mg lumefantrine RS in a 100 ml volumetric flask. Add approxi-
mately 85 ml of solvent, sonicate until dissolved, allow to cool to room temperature
and dilute to volume.

Operate with a flow rate of 1.3 ml per minute. As a detector use an ultraviolet spectro-
photometer set at a wavelength of about 210 nm for the first 28 minutes and then
switch to about 380 nm.

Inject alternately 20 µl each of solutions (1) and (2). (The peak for artemether is eluted
at a retention time of approximately 19 minutes, and that for lumefantrine at a reten-
tion time of approximately 34 minutes.)

Measure the areas of the peak responses obtained in the chromatograms from
solutions (1) and (2), and calculate the content of artemether (C16H26O5) and lumefan-
trine (C30H32Cl3NO).

Impurities (artemether-related)

Dihydroartemisinin 284.4 C15H24O5

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International Pharmacopoeia WHO Drug Information Vol 21, No. 2, 2007

α-artemether 298.4 C16H26O5

B. 298.4 C16H26O5

A. 238.3 C14H22O3

[Names to be provided for A and B]

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WHO Drug Information Vol 21, No. 2, 2007 International Pharmacopoeia

Magnesi sulfatis injectio

Magnesium sulfate Injection

Draft proposal for the International Pharmacopoeia (March 2007). Please

address any comments to Quality Assurance and Safety: Medicines, Medi-
cines Policy and Standards, World Health Organization, 1211 Geneva 27,
Switzerland. Fax: ++41 22 791 4730 or e-mail to rabhouansm@who.int

Note from the Secretariat: Inclusion of a monograph for magnesium sulfate

injection is considered advisable in view of the potential for errors in dosage
due to confusion concerning the strength of this injection since “Magnesium
sulfate” is the heptahydrate (mol wt 246.5 compared with 120 for anhydrous
substance). This injection is included in the WHO Model List of Essential
Medicines and within the “Making Pregnancy Safer” programme of the Family
and Community Health cluster of WHO.

Description. A clear, colourless solution.

Category. Used in the prevention of seizures in eclampsia and pre-eclampsia.

Labelling. The designation of the container of Magnesium sulfate injection should

indicate the quantity in terms of the amount of magnesium sulfate heptahydrate and
as the approximate concentration of magnesium ions (Mg2+) in millimoles per ml.

Additional information. Strength in the current WHO Model list of essential medi-
cines: 500 mg of magnesium heptahydrate /ml; the concentration of magnesium ions
(Mg2+) is approximately
2 millimoles per ml (2 mmolMg2+/ml).

REQUIREMENTS
Complies with the monograph for “Parenteral Preparations”.

Definition. Magnesium sulfate injection is a sterile solution of Magnesium Sulfate

Heptahydrate in water for injections. The solution is sterilized by “Heating in an Auto-
clave” or by another suitable method (see 5.8 Methods of Sterilization).

Magnesium sulfate injection contains not less than 90.0% and not more than 110.0%
of the amount of MgSO4,7H2O stated on the label.

Identity tests
A. Dilute the injection to give a solution containing 5 mg of magnesium sulfate
heptahydrate per ml. To 2 ml of this solution, add 1 ml of ammonia (100g/l) TS; a white
precipitate is produced which redissolves after adding 1 ml of ammonium chloride
(100g/l) TS. Add 1 ml of disodium hydrogen phosphate (40g/l) TS; a white, fine crystal-
line precipitate is formed.

B. Dilute the injection to give a solution containing 20 mg of magnesium sulfate

heptahydrate per ml; yields reaction A described under 2.1 General identification tests
as characteristic of sulfates.

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International Pharmacopoeia WHO Drug Information Vol 21, No. 2, 2007

pH value. (1.13) pH of the injection, diluted if necessary to contain 500 mg of magne-

sium sulfate heptahydrate /ml: 5.5 - 7.0.

Assay. Dilute an accurately measured volume of the injection containing about 0.50 g
of magnesium sulfate heptahydrate to 100 ml with water R and proceed with the
titration as described under 2.5 Complexometric titrations for magnesium. Each ml of
disodium edetate (0.05 mol/l) VS is equivalent to 12.32 mg of MGSO4, 7H2O

Zinci sulfas
Zinc sulfate
Zinc sulfate monohydrate
Zinc sulfate heptahydrate

Draft proposal for the International Pharmacopoeia (March 2007). Please

address any comments to Quality Assurance and Safety: Medicines, Medi-
cines Policy and Standards, World Health Organization, 1211 Geneva 27,
Switzerland. Fax: ++41 22 791 4730 or e-mail to rabhouansm@who.int

Note from the Secretariat: Preparation of the zinc monographs was initiated
because zinc supplementation is included in the revised the WHO/UNICEF
recommendations for the management of diarrhoea as an adjunct to oral
rehydration therapy.]

ZnSO4,H2O (monohydrate); ZnSO4,7H2O (heptahydrate)

Relative molecular mass. 179.5 (monohydrate); 287.5 (heptahydrate).

Chemical name. Zinc sulfate monohydrate; CAS Reg. No. 7446-19-7 (monohydrate).
Zinc sulfate heptahydrate; CAS Reg. No. 7446-20-0 (heptahydrate).

Description. A white or almost white, crystalline powder, or colourless, transparent

crystals.

Solubility. Very soluble in water, practically insoluble in ethanol (~750 g/l) TS.

Category. Adjunct to oral rehydration salts in( prevention and) treatment of dehydra-
tion due to diarrhoea; astringent.

Storage. Zinc sulfate should be kept in a well-closed non-metallic container.

REQUIREMENTS

Definition. Zinc sulfate monohydrate contains not less than 99.0% and not more than
101.0% of ZnSO4,H2O. Zinc sulfate heptahydrate contains not less than 99.0% and not
more than 104.0% of ZnSO4,7H2O.

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WHO Drug Information Vol 21, No. 2, 2007 International Pharmacopoeia

Identity tests

A. Dissolve 0.25 g in 5 ml of water R and add 0.2 ml of sodium hydroxide (400 g/l) TS.
A white precipitate is formed. Add a further 2 ml of sodium hydroxide (400 g/l) TS. The
precipitate dissolves. Add 10 ml of ammonium chloride (100 g/l) TS. The solution
remains clear. Add 0.1 ml of sodium sulfite TS. A flocculent white precipitate is
formed.

B. A 50 mg/ml solution yields the reactions described under 2.1 General identification
tests as characteristic of sulfates.

C. The test substance complies with the limits of the assay.

pH value. (1.13) pH of a 50 mg/ml solution in carbon-dioxide-free water R, 4.4-5.6.

Chlorides. Use 0.83 g in 20 ml for the preparation of the test solution as described
under 2.2.1 Limit test for chlorides; not more than 300 ìg/g.

Iron. Use 0.40 g for the preparation of the test solution as described under 2.2.4
Limit test for iron; not more than 100 ìg/g.

Assay

For the monohydrate Dissolve about 80 mg, accurately weighed, in 5 ml of acetic

acid (~120 g/l) TS and proceed with the titration as described under 2.5
Complexometric titrations for zinc. Each ml of disodium edetate (0.05 mol/l) VS is
equivalent to 8.975 mg of ZnSO4,H2O.

For the heptahydrate Dissolve about 0.13 g, accurately weighed, in 5 ml of acetic

acid (~120 g/l) TS and proceed with the titration as described under 2.5
Complexometric titrations for zinc. Each ml of disodium edetate (0.05 mol/l) VS is
equivalent to 1.438 g of ZnSO4,7H2O.

Paediatric zinc sulfate tablets

Draft proposal for the International Pharmacopoeia (March 2007). Please
address any comments to Quality Assurance and Safety: Medicines, Medi-
cines Policy and Standards, World Health Organization, 1211 Geneva 27,
Switzerland. Fax: ++41 22 791 4730 or e-mail to rabhouansm@who.int

Note from the Secretariat: The term “paediatric” has been used in the title
of this monograph since these tablets are included in the WHO Model List of
Essential Medicines (revised March 2005) under “medicines for diarrhoea in
children” (section17.5.2).

Preparation of the zinc monographs was initiated because zinc supplementa-

tion is included in the revised the WHO/UNICEF recommendations for the
management of diarrhoea as an adjunct to oral rehydration therapy.

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International Pharmacopoeia WHO Drug Information Vol 21, No. 2, 2007

Category. Adjunct to oral rehydration salts in (prevention and) treatment of dehydra-

tion due to diarrhoea.

Storage. Paediatric zinc sulfate tablets should be kept in a well-closed container.

Labelling. The designation of the container of Paediatric zinc sulfate tablets should
state that the active ingredient is in the monohydrate form and indicate the quantity in
terms of the equivalent amount of elemental zinc.

Additional information. Strength in the current WHO Model list of essential medi-
cines: 10 mg of elemental zinc (as zinc sulfate monohydrate).

REQUIREMENTS

Comply with the monograph for “Tablets”.

Definition. Paediatric zinc sulfate tablets contain Zinc Sulfate as the monohydrate in
a suitable dispersible basis that may contain suitable flavouring agents. They contain
not less than 90.0% and not more than 110.0% of the amount of zinc stated on the
label.

Manufacture. The formulation of the tablets and the manufacturing process are
designed and controlled so as to ensure that the metallic taste of the zinc salt is
adequately masked.

Identity tests. For solution (A) shake a quantity of the powdered tablets containing
the equivalent of 100 mg of zinc with 20 ml, filter, and use the clear filtrate.

A. To 5 ml of solution (A) add 0.2 ml of sodium hydroxide (400 g/l) TS. A white precipi-
tate is formed. Add a further 2 ml of sodium hydroxide (400 g/l) TS. The precipitate
dissolves. Add 10 ml of ammonium chloride (100 g/l) TS. The solution remains clear.
Add 0.1 ml of sodium sulfite TS. A flocculent white precipitate is formed.

B. Five ml of solution (A) yields reaction A described under 2.1 General identification
tests as characteristic of sulfates.

Disintegration. Comply with 5.4 Disintegration test for tablets and capsules, operat-
ing the apparatus for 60 seconds.

Assay. Weigh and powder 20 tablets. To a quantity of the powder equivalent to about
29 mg of zinc, accurately weighed, add 5 ml of acetic acid (~120 g/l), sonicate for 15
minutes and add about 50 ml water R. Proceed with the titration as described under
2.5 Complexometric titrations for zinc. Each ml of disodium edetate (0.05 mol/l) VS is
equivalent to 3.27 mg of zinc.

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WHO Drug Information Vol 21, No. 2, 2007 International Pharmacopoeia

Paediatric zinc sulfate oral solution

Draft proposal for the International Pharmacopoeia (March 2007). Please
address any comments to Quality Assurance and Safety: Medicines, Medi-
cines Policy and Standards, World Health Organization, 1211 Geneva 27,
Switzerland. Fax: ++41 22 791 4730 or e-mail to rabhouansm@who.int

Note from the Secretariat: The term “paediatric” has been used in the title of
this monograph since these tablets are included in the WHO Model List of
Essential Medicines (revised March 2005) under “medicines for diarrhoea in
children” (section17.5.2).

Preparation of the zinc monographs was initiated because zinc supplementa-

tion is included in the revised the WHO/UNICEF recommendations for the
management of diarrhoea as an adjunct to oral rehydration therapy.

Category. Adjunct to oral rehydration salts in (prevention and) treatment of dehydra-

tion due to diarrhoea.

Storage. Paediatric zinc sulfate oral solution should be kept in a well-closed con-
tainer.

Labelling. The designation of the container of Paediatric zinc sulfate oral solution
should indicate the quantity in terms of the equivalent amount of elemental zinc.

Additional information. Strength in the current WHO Model list of essential medi-
cines: 10 mg of zinc (as zinc sulfate) per 5 ml.

REQUIREMENTS

Complies with the monograph for “Liquids for Oral Use”.

Definition. Paediatric zinc sulfate oral solution is a solution of Zinc Sulfate as the
monohydrate or heptahydrate in a suitable flavoured vehicle. It contains not less than
90.0% and not more than 110.0% of the amount of zinc stated on the label.

Manufacture. The formulation of the oral solution and the manufacturing process are
designed and controlled so as to ensure that the metallic taste of the zinc salt is
adequately masked.

Identity tests

A. To 5 ml add 0.2 ml of sodium hydroxide (400 g/l) TS. A white precipitate is formed.
Add a further 2 ml of sodium hydroxide (400 g/l) TS. The precipitate dissolves. Add 10
ml of ammonium chloride (100 g/l) TS. The solution remains clear. Add 0.1 ml of
sodium sulfite TS. A flocculent white precipitate is formed.

B. Five ml yields reaction A described under 2.1 General identification tests as charac-
teristic of sulfates.

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International Pharmacopoeia WHO Drug Information Vol 21, No. 2, 2007

pH value. (1.13) pH of the oral solution: 2.5–4.5.

Relative density

Note from the Secretariat: Comment is invited as to whether inclusion of a require-

ment for relative density is advisable and, if so, what limits would be considered suit-
able using method 1.3 of Ph. Int. (20 ˚C).

Assay. To a quantity of the oral solution equivalent to about 10 mg of zinc, accurately

measured, add 50 ml of purified water and 5 ml of ammonia buffer TS and titrate with
disodium edetate (0.01 mol/l) VS using Mordant Black 11 indicator mixture R as indica-
tor. Each ml of disodium edetate (0.01 mol/l) VS is equivalent to 0.6539 mg of zinc.

128
WHO Drug Information Vol 21, No. 2, 2007
Recent Publications,
Information and Events
Informed consent for research Technological and financial resources are
in resource-poor settings also necessary to build capacity for local
Ethical challenges in study design and
informed consent for health research in
resource-poor settings considers ethical
challenges to research design and
informed consent in biomedical and
behavioural studies conducted in re-
source-poor settings. A review of the
literature explores relevant social, cul-
tural, and ethical issues in the conduct of
biomedical and social health research in
developing countries. Ten case vignettes
illustrate ethical challenges that arise in
international research with culturally
diverse populations.
Professional and public debates concern-
ing the application of guidelines for
ethical conduct in studies carried out in
developing countries are likely to continue
as new information becomes available.
Researchers in biomedicine, public
health, and the social and behavioural
sciences confront the challenging task of
adhering to national and international
regulations in social and cultural environ-
ments in which ethical guidelines may not
be easily translated or applied. Increased
awareness of ethical concerns associated
with study design and informed consent
among researchers working in resource-
poor settings is needed. But strengthen-
ing professional knowledge about interna-
tional research ethics is not enough.
Investigators also require practical advice
on the best methods or models for
articulating ethical guidelines in the field.
Empirical research on a wide range of
issues relevant to the application of
ethical guidelines is needed, including
studies of macro social and economic
developments that drive the globalization
of the biomedical research enterprise.
collaborators and communities to ensure
that results of research are integrated into
existing health systems. This requires
collaborative efforts and engaged com-
mitment on the part of investigators,
funding agencies, policy-makers, govern-
mental institutions, and industry.
Reference: Ethical
challenges in study
design and informed
consent for health
research in re-
source-poor settings
http:// www.who.int/
tdr/publications/
publications/
seb_topic5.htm
UNDP/WorldBank/
WHO-TDR http://
www.who.int/tdr/
topmenu/news/
Lessons learned in home
management of malaria
Implementation research in four
African countries
Studies on treatment-seeking behaviour
have shown that most malaria episodes
are first treated at home using shop-
bought drugs. Part of the reason for this
is poor access to formal health services.
These treatments may be incorrect or
suboptimal. Since the majority of children
who die from malaria do so within 48
hours of onset of illness, the early use of
effective antimalaria medicines close to
the home can help to reduce the burden
of the disease in sub-Saharan Africa and
minimize the life-threatening conse-
quences of treatment delays.
129
Recent Publications, Information and Events
This guide focuses in particular on four
countries – Burkina Faso, Ghana, Nigeria
and Uganda – where country teams have
completed community based studies in
home management of malaria.
Reference: World
Health Organiza-
tion. Lessons
learned in Home
Management of
Malaria. Imple-
mentation re-
search in four
African countries,
2007
Developing drug information
centres in India
A unique training workshop was organ-
ized in Bangalore in December 2006.
Participants from India were provided with
an introduction to drug information
practice and rational drug use. The
course was a part of a programme to
expand the influence of the drug informa-
tion centres and clinical pharmacy train-
ing programmes which have developed in
the south of India over the last ten years.
The current programme is being coordi-
nated by the Karnataka State Pharmacy
Council (KSPC) and is funded by WHO
(India Office). KSPC established a drug
information centre in 1997 and also works
with hospital-based clinical pharmacy
training programs in Bangalore. Other
departments of pharmacy practice in
south India include drug information
training in their clinical programs and offer
independent information to clinicians
within their institutions.
The centres will provide information to
healthcare professionals and the public,
and will collect reports of suspected
adverse drug reactions. Limited funding
will be provided to purchase information
resources but long-term support will be
required at the state level.
130
WHO Drug Information Vol 21, No. 2, 2007
Reference: FIP pharmacy information section
newsletter. March 2007 www.fip.org
First-in-man clinical trials
for high risk products
European Union — The Committee for
Medicinal Products for Human Use
(CHMP) has adapted a draft guideline for
first-in-man clinical trials for potential
high-risk medicinal products. This guide-
line has been prepared as one of the
measures for minimizing the risk of
serious adverse reactions of the nature
that occurred during the first-in-man
clinical trials of TGN1412 (gene therapy).
It gives guidance on managing the
transition from non-clinical studies to first
tests in humans for high-risk medicinal
products. The draft guideline has been
released for a two-month public consulta-
tion.
Reference: Press Release. EMEA, 26 March
2007. http://www.emea.europa.eu
Pakistan Pharmacists Society
discussion forum
The Pakistan Pharmacists Society
promotes and expands the profession of
pharmacy and the role of pharmacists. In
order to improve drug use and pharmacy
practice in the country, the Society has
launched a website to serve as an online
source of news, pharmacy jobs, and to
provde an opportunity for pharmacists to
link up, share ideas and develop activities
of interest.
Reference: Pakistan Pharmacists Society
(PPS) http:// www.pharmacist.pk and http://
www. pharmacy.org.pk
New quality assurance
compendium
Over the years, WHO’s Expert Committee
on Specifications for Pharmaceutical
Preparations has made numerous
recommendations to establish standards
WHO Drug Information Vol 21, No. 2, 2007
and guidelines and to promote the
effective functioning of national regulatory
and control systems and implementation
of internationally agreed standards.
Many of the relevant documents en-
dorsed by the Expert Committee are
reproduced in a recently published
compendium of guidelines and related
materials Quality Assurance of Pharma-
ceuticals. Second Edition aiming to
provide information covering all aspects
of WHO good manufacturing practices
and inspection. The compendium in-
cludes.
1. WHO good manufacturing practices:
main principles for pharmaceutical
products
• Quality management in the drug indus-
try: philosophy and essential elements
• Heating Ventilation and air-conditioning
systems for non-sterile pharmaceutical
dosage forms
• Validation
• Water for pharmaceutical use
2. WHO good manufacturing practices:
starting materials
• Active pharmaceutical ingredients (bulk
drug substances)
• Pharmaceutical excipients
3. WHO good manufacturing practices:
specific pharmaceutical products
• Sterile pharmaceutical products
• Biological products
• Investigational pharmaceutical products
for clinical trials in humans
• The manufacture of herbal medicines
• Radiopharmaceutical products
Recent Publications, Information and Events
4. Inspection
• Pre-approval inspections
• Inspection of pharmaceutical manufac-
turers
• Inspection of drug distribution channels
• Quality systems requirements for
national good manufacturingbpractice
inspectorates
• Guidance on good manufacturing
practices: inspection report
• Model certificate of good manufacturing
practices
5. Hazard and risk analysis in pharma-
ceutical products
• Application of hazard analysis and
critical control point (HACCP) methodol-
ogy to pharmaceuticals
6. Sampling operations
• Sampling of pharmaceutical products
and related materials
Reference: Quality Assurance of Pharmaceu-
ticals. Second Edition. http://www.who.int/
bookorders
Pharmacological management
of human H5N1 infection
The recent geographical spread of highly
pathogenic avian influenza A virus in
poultry and wild waterfowl has increased
opportunities for transmission of the
H5N1 virus to humans. Outbreaks in
poultry have now been accompanied by
human cases in nine countries. To date,
human cases have remained rare and
sporadic, but the disease is very severe
and the case fatality is high. With the
H5N1 virus now confirmed in birds in
more than 50 countries, additional spo-
radic human cases should be anticipated.
131
Recent Publications, Information and Events
Although international experts agree that
antiviral drugs should be considered for
treatment of H5N1 patients and also for
chemoprophylaxis, the efficacy and
effectiveness of these management
options have not been systematically
assessed. Guidance on their use is
needed worldwide.
In March 2006, the World Health Organi-
zation (WHO) convened an international
panel of clinicians experienced in the
treatment of H5N1 patients, infectious
disease experts, public health officers
and methodologists to develop rapid
advice for the pharmacological manage-
ment of patients with H5N1 infection. To
develop evidence-based guidelines, the
panel used a transparent methodological
guideline process, based on the GRADE
approach, that included evaluation of
existing systematic reviews, literature
searches and expert consultation. The
resulting guidelines separate strong from
weak recommendations for or against a
specific action and assign four categories
of quality of evidence (high, moderate,
low and very low).
The panel considered several different
specific patient and exposure groups and
made a number of strong recommenda-
tions for or against specific actions
regarding the treatment and chemo-
prophylaxis of H5N1 virus infection. All
recommendations are specific to the
132
WHO Drug Information Vol 21, No. 2, 2007
current pre-pandemic situation. Recom-
mendations were based on careful
consideration of the benefits, harms,
burdens and cost of interventions. Risk
categorizations for exposure were devel-
oped to assist countries in prioritizing the
use of antiviral drugs where their
availability is limited.
Overall, the quality of the underlying
evidence for all recommendations was
very low. No data from controlled clinical
trials of H5N1 infection are available. The
existing evidence is based on small
observational case series of H5N1
patients, results from in vitro and animal
model studies of H5N1, or the extrapola-
tion of data from high quality studies
conducted to evaluate the treatment and
chemoprophylaxis of normal, or “sea-
sonal”, influenza. These shortcomings
highlight the need for further research.
While the quality of the evidence for some
of the critical outcomes was moderate or
low, the overall quality of evidence on
which to base a summary assessment
was very low for all antiviral drugs.
Differences exist in the quality of evi-
dence for individual critical outcomes
among the various antiviral drugs (annex
3 sets out the gradings and ratings).
Reference: World Health Organization. WHO
Rapid Advice Guidelines on pharmacological
management of humans infected with avian
influenza A (H5N1) virus. WHO/PSM/PAR/
2006 at http://www.who.int/medicines
WHO Drug Information, Vol. 21, No. 2, 2007 Proposed INN: List 97

International Nonproprietary Names for

Pharmaceutical Substances (INN)
Notice is hereby given that, in accordance with article 3 of the Procedure for the Selection of Recommended International
Nonproprietary Names for Pharmaceutical Substances, the names given in the list on the following pages are under
consideration by the World Health Organization as Proposed International Nonproprietary Names. The inclusion of a name
in the lists of Proposed International Nonproprietary Names does not imply any recommendation of the use of the substance
in medicine or pharmacy.

Lists of Proposed (1–96) and Recommended (1–57) International Nonproprietary Names can be found in Cumulative List
No. 12, 2007 (available in CD-ROM only). The statements indicating action and use are based largely on information
supplied by the manufacturer. This information is merely meant to provide an indication of the potential use of new
substances at the time they are accorded Proposed International Nonproprietary Names. WHO is not in a position either to
uphold these statements or to comment on the efficacy of the action claimed. Because of their provisional nature, these
descriptors will neither be revised nor included in the Cumulative Lists of INNs.

Dénominations communes internationales des

Substances pharmaceutiques (DCI)
Il est notifié que, conformément aux dispositions de l'article 3 de la Procédure à suivre en vue du choix de Dénominations
communes internationales recommandées pour les Substances pharmaceutiques les dénominations ci-dessous sont mises
à l'étude par l'Organisation mondiale de la Santé en tant que dénominations communes internationales proposées.
L'inclusion d'une dénomination dans les listes de DCI proposées n'implique aucune recommandation en vue de l'utilisation
de la substance correspondante en médecine ou en pharmacie.

On trouvera d'autres listes de Dénominations communes internationales proposées (1–96) et recommandées (1–57) dans
la Liste récapitulative No. 12, 2007 (disponible sur CD-ROM seulement). Les mentions indiquant les propriétés et les
indications des substances sont fondées sur les renseignements communiqués par le fabricant. Elles ne visent qu'à donner
une idée de l'utilisation potentielle des nouvelles substances au moment où elles sont l'objet de propositions de DCI. L'OMS
n'est pas en mesure de confirmer ces déclarations ni de faire de commentaires sur l'efficacité du mode d'action ainsi décrit.
En raison de leur caractère provisoire, ces informations ne figureront pas dans les listes récapitulatives de DCI.

Denominaciones Comunes Internacionales para

las Sustancias Farmacéuticas (DCI)
De conformidad con lo que dispone el párrafo 3 del "Procedimiento de Selección de Denominaciones Comunes
Internacionales Recomendadas para las Sustancias Farmacéuticas", se comunica por el presente anuncio que las
denominaciones detalladas en las páginas siguientes están sometidas a estudio por la Organización Mundial de La Salud
como Denominaciones Comunes Internacionales Propuestas. La inclusión de una denominación en las listas de las DCI
Propuestas no supone recomendación alguna en favor del empleo de la sustancia respectiva en medicina o en farmacia.

Las listas de Denominaciones Comunes Internacionales Propuestas (1–96) y Recomendadas (1–57) se encuentran
reunidas en Cumulative List No. 12, 2007 (disponible sólo en CD-ROM). Las indicaciones sobre acción y uso que aparecen
se basan principalmente en la información facilitada por los fabricantes. Esta información tiene por objeto dar una idea
únicamente de las posibilidades de aplicación de las nuevas sustancias a las que se asigna una DCI Propuesta. La OMS
no está facultada para respaldar esas indicaciones ni para formular comentarios sobre la eficacia de la acción que se
atribuye al producto. Debido a su carácter provisional, esos datos descriptivos no deben incluirse en las listas
recapitulativas de DCI.

133
Proposed INN: List 97 WHO Drug Information, Vol. 21, No. 2, 2007

Proposed International Nonproprietary Names: List 97

Comments on, or formal objections to, the proposed names may be forwarded by any person to the INN Programme of the
World Health Organization within four months of the date of their publication in WHO Drug Information, i.e., for List 97
st
Proposed INN not later than 31 of October 2007.
th
Publication date: 25 of June 2007

Dénominations communes internationales proposées: Liste 97

Des observations ou des objections formelles à l'égard des dénominations proposées peuvent être adressées par toute
personne au Programme des Dénominations communes internationales de l'Organisation mondiale de la Santé dans un
délai de quatre mois à compter de la date de leur publication dans WHO Drug Information, c'est à dire pour la Liste 97 de
DCI Proposées le 31 octobre 2007 au plus tard.
Date de Publication: 25 juin 2007

Denominaciones Comunes Internacionales Propuestas: Lista 97

Cualquier persona puede dirigir observaciones u objeciones respecto de las denominaciones propuestas, al Programa de
Denominaciones Comunes Internacionales de la Organización Mundial de la Salud, en un plazo de cuatro meses, contados
desde la fecha de su publicación en WHO Drug Information, es decir, para la Lista 97 de DCI Propuestas el 31 de
Octubre de 2007 a más tardar.
Fecha de publicación: el 25 de Juno de 2007.

Proposed INN Chemical name or description: Action and use: Molecular formula
(Latin, English, French, Spanish) Chemical Abstracts Service (CAS) registry number: Graphic formula

DCI Proposée Nom chimique ou description: Propriétés et indications: Formule brute

Numéro dans le registre du CAS: Formule développée

DCI Propuesta Nombre químico o descripción: Acción y uso: Fórmula molecular

Número de registro del CAS: Fórmula desarrollada

alaninati brivanibum
brivanib alaninate (2R)-1-({4-[(4-fluoro-2-methyl-1H-indol-5-yl)oxy]-5-methylpyrrolo
[2,1-f][1,2,4]triazin-6-yl}oxy)propan-2-yl L-alaninate
angiogenesis inhibitor

alaninate de brivanib L-alaninate de (2R)-1-({4-[(4-fluoro-2-méthyl-1H-indol-5-yl)oxy]-

5-méthylpyrrolo[2,1-f][1,2,4]triazin-6-yl}oxy)propan-2-yle
inhibiteur de l'angiogénèse

alaninato de brivanib L-alaninato de (2R)-1-({4-[(4-fluoro-2-metil-1H-indol-5-il)oxi]-

5-metilpirrolo[2,1-f][1,2,4]triazin-6-il}oxi)propan-2-ilo
inhibidor de la angiogénesis

C22H24FN5O4 649735-63-7

N
N N
H CH3
O
H2N O O NH
O H CH3 CH3
F CH3

134
WHO Drug Information, Vol. 21, No. 2, 2007 Proposed INN: List 97

albiglutidum*
albiglutide ([8-glycine]human glucagon-like peptide 1-(7-36)-peptidyl)
([8-glycine]human glucagon-like peptide 1-(7-36)-peptidyl)(human
serum albumin (585 residues))
antidiabetic

albiglutide ([8-glycine]peptide 1 analogue au glucagon humain-(7-36)-

peptidyl)([8-glycine]peptide 1 analogue au glucagon humain-(7-36)-
peptidyl)(albumine sérique humaine (585 aminoacides))
antidiabétique

albiglutida ([8-glicina]péptido1 análogo al glucagón humano-(7-36)-peptidil)

([8-glicina]péptido 1 análogo al glucagón humano-(7-36)-
peptidil)(albumina séria humana (585 aminoácidos))
antidiabético

C3232H5032N864O979S41 782500-75-8

HGEGTFTSDV SSYLEGQAAK EFIAWLVKGR HGEGTFTSDV SSYLEGQAAK 50

EFIAWLVKGR DAHKSEVAHR FKDLGEENFK ALVLIAFAQY LQQCPFEDHV 100
KLVNEVTEFA KTCVADESAE NCDKSLHTLF GDKLCTVATL RETYGEMADC 150
CAKQEPERNE CFLQHKDDNP NLPRLVRPEV DVMCTAFHDN EETFLKKYLY 200
EIARRHPYFY APELLFFAKR YKAAFTECCQ AADKAACLLP KLDELRDEGK 250
ASSAKQRLKC ASLQKFGERA FKAWAVARLS QRFPKAEFAE VSKLVTDLTK 300
VHTECCHGDL LECADDRADL AKYICENQDS ISSKLKECCE KPLLEKSHCI 350
AEVENDEMPA DLPSLAADFV ESKDVCKNYA EAKDVFLGMF LYEYARRHPD 400
YSVVLLLRLA KTYETTLEKC CAAADPHECY AKVFDEFKPL VEEPQNLIKQ 450
NCELFEQLGE YKFQNALLVR YTKKVPQVST PTLVEVSRNL GKVGSKCCKH 500
PEAKRMPCAE DYLSVVLNQL CVLHEKTPVS DRVTKCCTES LVNRRPCFSA 550
LEVDETYVPK EFNAETFTFH ADICTLSEKE RQIKKQTALV ELVKHKPKAT 600
KEQLKAVMDD FAAFVEKCCK ADDKETCFAE EGKKLVAASQ AALGL 645

Disulfide bridges location Position des ponts disulfure / Posiciones de los puentes disulfuro
113-122 135-151 150-161 184-229 228-237 260-306 305-313 325-339 338-349
376-421 420-429 452-498 497-508 521-537 536-547 574-619 618-627

albinterferonum alfa-2b*
albinterferon alfa-2b human serum albumin (585 residues) fusion protein with human
interferon α-2b (165 residues)
antiviral

albinterféron alfa-2b protéine de fusion entre l’albumine sérique humaine (585

aminoacides) et l'interféron α-2b humain (165 aminoacides)
antiviral

albinterferón alfa 2b proteína de fusión entre la albumina sérica humana (585

aminoácidos) y el interferón α-2b humano (165 aminoácidos)
antiviral

135
Proposed INN: List 97 WHO Drug Information, Vol. 21, No. 2, 2007

C3796H5937N1015O1143S50 472960-22-8

DAHKSEVAHR FKDLGEENFK ALVLIAFAQY LQQCPFEDHV KLVNEVTEFA 50

KTCVADESAE NCDKSLHTLF GDKLCTVATL RETYGEMADC CAKQEPERNE 100
CFLQHKDDNP NLPRLVRPEV DVMCTAFHDN EETFLKKYLY EIARRHPYFY 150
APELLFFAKR YKAAFTECCQ AADKAACLLP KLDELRDEGK ASSAKQRLKC 200
ASLQKFGERA FKAWAVARLS QRFPKAEFAE VSKLVTDLTK VHTECCHGDL 250
LECADDRADL AKYICENQDS ISSKLKECCE KPLLEKSHCI AEVENDEMPA 300
DLPSLAADFV ESKDVCKNYA EAKDVFLGMF LYEYARRHPD YSVVLLLRLA 350
KTYETTLEKC CAAADPHECY AKVFDEFKPL VEEPQNLIKQ NCELFEQLGE 400
YKFQNALLVR YTKKVPQVST PTLVEVSRNL GKVGSKCCKH PEAKRMPCAE 450
DYLSVVLNQL CVLHEKTPVS DRVTKCCTES LVNRRPCFSA LEVDETYVPK 500
EFNAETFTFH ADICTLSEKE RQIKKQTALV ELVKHKPKAT KEQLKAVMDD 550
FAAFVEKCCK ADDKETCFAE EGKKLVAASQ AALGLCDLPQ THSLGSRRTL 600
MLLAQMRRIS LFSCLKDRHD FGFPQEEFGN QFQKAETIPV LHEMIQQIFN 650
LFSTKDSSAA WDETLLDKFY TELYQQLNDL EACVIQGVGV TETPLMKEDS 700
ILAVRKYFQR ITLYLKEKKY SPCAWEVVRA EIMRSFSLST NLQESLRSKE 750

Disulfide bridges location / Position des ponts disulfure / Posiciones de los puentes disulfuro
53-62 75-91 90-101 124-169 168-177 200-246 245-253 265-279
278-289 316-361 360-369 392-438 437-448 461-477 476-487 514-559
558-567 586-683 614-723

Glycosylation sites : N-318 T-691

anamorelinum
anamorelin (3R)-3-benzyl-N,N',N'-trimethyl-1-(2-methylalanyl-D-tryptophyl)=
piperidine-3-carbohydrazide
growth hormone-releasing factor

anamoréline (3R)-3-benzyl-N,N',N'-triméthyl-1-(2-méthylalanyl-D-tryptophyl)=
pipéridine-3-carbohydrazide
facteur de libération de l'hormone de croissance

anamorelina (3R)-3-bencil-N,N',N'-trimetil-1-(2-metilalanil-D-triptofil)piperidina-
3-carbohidrazida
factor estimulante de la liberación de la hormona del crecimiento

C31H42N6O3 249921-19-5

H3C CH3 O O CH3

H
N N
H2N N N CH3
O H CH3

HN

apremilastum
apremilast N-{2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methanesulfonyl)ethyl]-
1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}acetamide
antiasthmatic

aprémilast N-{2-[(1S)-1-(3-éthoxy-4-méthoxyphényl)-2-(méthanesulfonyl)éthyl]-
1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}acétamide
antiasthmatique

apremilast N-{2-[(1S)-1-(3-etoxy-4-metoxifenil)-2-(metansulfonil)etil]-1,3-dioxo-
2,3-dihidro-1H-isoindol-4-il}acetamida
antiasmático

136
WHO Drug Information, Vol. 21, No. 2, 2007 Proposed INN: List 97

C22H24N2O7S 608141-41-9

O O
O S
CH3
H
N
CH3
H3 C NH O O

O OCH3

arbaclofenum placarbilum
arbaclofen placarbil (3R)-3-(4-chlorophenyl)-4-[({(1S)-2-methyl-1-[(2-methylpropanoyl)=
oxy]propoxy}carbonyl)amino]butanoic acid
antispasmodic

arbaclofène placarbil acide (3R)-3-(4-chlorophényl)-4-[({(1S)-2-méthyl-

1-[(2-méthylpropanoyl)oxy]propoxy}carbonyl)amino]butanoïque
antispasmodique

arbaclofeno placarbilo ácido (3R)-3-(4-clorofenil)-4-[({(1S)-2-metil-1-[(2-metilpropanoil)oxi]=

propoxi}carbonil)amino]butanoico
antiespasmódico

C19H26ClNO6 847353-30-4

H3C CH3
O O
H
H3C
O O N CO2H
H
CH3 H

Cl

arterolanum
arterolane N-(2-amino-2-methylpropyl)-2-{cis-dispiro[adamantane-
2,3'-[1,2,4]trioxolane-5',1"-cyclohexan]-4"-yl}acetamide
antimalarial

artérolane N-(2-amino-2-methylpropyl)-2-{cis-dispiro[adamantane-
2,3'-[1,2,4]trioxolane-5',1"-cyclohexan]-4"-yl}acétamide
antipaludique

arterolano N-(2-amino-2-metilpropil)-2-{cis-dispiro[adamantano-
2,3'-[1,2,4]trioxolano-5',1"-ciclohexan]-4"-il}acetamida
antipalúdico

C22H36N2O4 664338-39-0

O O
O H
CH3
N
O H
H2N CH3

137
Proposed INN: List 97 WHO Drug Information, Vol. 21, No. 2, 2007

azilsartanum medoxomilum
azilsartan medoxomil (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(5-oxo-
4,5-dihydro-1,2,4-oxadiazol-3-yl)-1,1'-biphenyl-4-yl]methyl}-
1H-benzimidazol-7-carboxylate
angiotensine II receptor antagonist

azilsartan médoxomil 2-éthoxy-1-{[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-

1,1'-biphényl-4-yl]méthyl}-1H-benzimidazole-7-carboxylate de
(5-méthyl-2-oxo-1,3-dioxol-4-yl)méthyle
antagoniste du récepteur de l’angiotensine II

azilsartán medoxomilo 2-etoxi-1-{[2'-(5-oxo-4,5-dihidro-1,2,4-oxadiazol-3-il)-1,1'-bifenil-

4-il]metil}-1H-benzoimidazol-7-carboxilato de (5-metil-2-oxo-
1,3-dioxol-4-il)metilo
antagonista del receptor de la angiotensina II

C30H24N4O8 863031-24-7

O O

H3C O
O
O
O
HN N
N

N O

CH3

azoximeri bromidum
azoximer bromide poly{[1-(carboxymethyl)piperazin-1-ium-1,4-diyl bromide]ethylene-
co-[(piperazin-1,4-diyl 1-oxide)ethylene]}
immunomodulator

bromure d'azixomère poly{[bromure de 1-(carboxyméthyl)pipérazin-1-ium-

1,4-diyl]éthylène-co-[(1-oxyde de pipérazine-1,4-diyl)éthylène]}
immunomodulateur

bromuro de azoxímero poly{[bromuro de 1-(carboximetil)piperazin-1-io-1,4-diil]etileno-

co-[(1-óxido de piperazin-1,4-diil)etileno]}
inmunomodulador

[[C8H15BrN2O2]x[C6H12N2O]y]n 892497-01-7

CO2H

N+
N
Br x N N
O y
n

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begacestatum
begacestat 5-chloro-N-[(2S)-4,4,4-trifluoro-1-hydroxy-3-(trifluoromethyl)butan-
2-yl]thiophene-2-sulfonamide
gamma secretase inhibitor

bégacestat 5-chloro-N-[(2S)-4,4,4-trifluoro-1-hydroxy-3-(trifluorométhyl)butan-
2-yl]thiophène-2-sulfonamide
inhibiteur de la secrétase gamma

begacestat 5-cloro-N-[(2S)-4,4,4-trifluoro-1-hidroxi-3-(trifluorometil)butan-
2-il]tiofeno-2-sulfonamida
inhibidor de la secretasa gamma

C9H8ClF6NO3S2 769169-27-9

O O H OH
S S CF3
Cl N
H
CF3

belinostatum
belinostat N-hydroxy-3-[3-(N-phenylsulfamoyl)phenyl]prop-2-enamide
antitumour agent, inhibitor of histone deacetylase

bélinostat N-hydroxy-3-[3-(phénylsulfamoyl)phényl]prop-2-ènamide
agent antitumoral, inhibiteur de la déacétylase de l'histone

belinostat N-hidroxi-3-{3-[(fenilsulfamoil]fenil}prop-2-enamida
antitumoral, inhibidor de la desacetilasa de histona

C15H14N2O4S 414864-00-9

O
H OH
N N
S H
O O

boceprevirum
boceprevir (1R,2S,5S)-N-[(2Ξ)-4-amino-1-cyclobutyl-3,4-dioxobutan-2-yl)]-
3-{(2S)-2-[(tert-butylcarbamoyl)amino]-3,3-dimethylbutanoyl}-
6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide
antiviral

bocéprévir (1R,2S,5S)-N-[(2Ξ)-4-amino-1-cyclobutyl-3,4-dioxobutan-2-yl)]-
3-{(2S)-2-[(tert-butylcarbamoyl)amino]-3,3-diméthylbutanoyl}-
6,6-diméthyl-3-azabicyclo[3.1.0]hexane-2-carboxamide
antiviral

boceprevir (1R,2S,5S)-N-[(2Ξ)-4-amino-1-ciclobutil-3,4-dioxobutan-2-il)]-
3-{(2S)-2-[(terc-butilcarbamoil)amino]-3,3-dimetilbutanoil}-6,6-dimetil-
3-azabiciclo[3.1.0]hexano-2-carboxamida
antiviral

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C27H45N5O5 394730-60-0

CH3 CH3
H3C H
CH3 CH3
H3C CH3 O O
H
N H
H3C N N HN NH2
H H
O H
O H O

canakinumabum*
canakinumab immunoglobulin G1, anti-[Homo sapiens interleukin 1, beta (IL1B)]
human monoclonal ACZ885; gamma1 heavy chain (Homo sapiens
VH-IGHG1*03) (221-214’)-disulfide with kappa light chain (Homo
sapiens V-KAPPA-IGKC*01); (227-227’’:230-230’’)-bisdisulfide dimer
immunomodulator

canakinumab immunoglobuline G1, anti-[Homo sapiens interleukine 1, beta (IL1B)]

anticorps monoclonal humain ACZ885; chaîne lourde gamma1
(Homo sapiens VH-IGHG1*03) (221-214’)-disulfure avec la chaîne
légère kappa (Homo sapiens V-KAPPA-IGKC*01); dimère
(227-227’’:230-230’’)-bisdisulfure
immunomodulateur

canakinumab inmunoglobulina G1, anticuerpo monoclonal humano ACZ885

anti-[ interleukina 1 de Homo sapiens, beta (IL1B)]; cadena pesada
gamma1 (Homo sapiens VH-IGHG1*03) (221-214’)-disulfuro con la
cadena ligera kappa (Homo sapiens V-KAPPA-IGKC*01); dímero
(227-227’’:230-230’’)-bisdisulfuro
inmunomodulador

C6452H9958N1722O2010S42 Light chain 402710-27-4

Heavy chain 402710-25-2

carfilzomibum
carfilzomib {(2S)-2-[(morpholin-4-yl)acetamido]-4-phenylbutanoyl}-L-leucyl-
N1-{(2S)-1-[(2R)-2-methyloxiran-2-yl]-4-methyl-1-oxopentan-2-yl}-
L-phenylalaninamide
antineoplastic

carfilzomib {(2S)-2-[(morpholin-4-yl)acétamido]-4-phénylbutanoyl}-L-leucyl-
N1-{(2S)-1-[(2R)-2-méthyloxiran-2-yl]-4-méthyl-1-oxopentan-2-yl}-
L-phénylalaninamide
antinéoplasique

carfilzomib {(2S)-2-[(morfolin-4-il)acetamido]-4-fenilbutanoil}-L-leucil-
N1-{(2S)-1-[(2R)-2-metiloxiran-2-il]-4-metil-1-oxopentan-2-il}-
L-fenilalaninamida
antineoplásico

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C40H57N5O7 868540-17-4

O O H O H O
H H
N N N CH3
N N
H H
O H O H O
CH3 CH3
H3C H 3C

ceftarolinum fosamilum
ceftaroline fosamil (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-
1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-
1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-
2-carboxylate
antibiotic

céftaroline fosamil (6R,7R)-7-{(2Z)-2-(éthoxyimino)-2-[5-(phosphonoamino)-

1,2,4-thiadiazol-3-yl]acétamido}-3-{[4-(1-méthylpyridin-1-ium-4-yl)-
1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ène-
2-carboxylate
antibiotique

ceftarolina fosamilo (6R,7R)-7-{(2Z)-2-(etoxiimino)-2-[5-(fosfonoamino)-1,2,4-tiadiazol-

3-il]acetamido}-3-{[4-(1-metilpiridin-1-io-4-il)-1,3-tiazol-2-il]sulfanil}-
8-oxo-5-tia-1-azabiciclo[4.2.0]oct-2-eno-2-carboxilato
antibiótico

C22H21N8O8PS4 229016-73-3

CH3
CO2
O O S N
N N
H N+ CH3
N N S
S
S H H
HO N O
HO NH
P
O

cenersenum
cenersen antisense oligonucleotide inhibitor of p53 expression
2'-deoxy-P-thiocytidylyl-(3'→5')-2'-deoxy-P-thiocytidylyl-(3'→5')-
2'-deoxy-P-thiocytidylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-deoxy-
P-thioguanylyl-(3'→5')-2'-deoxy-P-thiocytidylyl-(3'→5')-
P-thiothymidylyl-(3'→5')-2'-deoxy-P-thiocytidylyl-(3'→5')-2'-deoxy-
P-thiocytidylyl-(3'→5')-2'-deoxy-P-thiocytidylyl-(3'→5')-2'-deoxy-
P-thiocytidylyl-(3'→5')-2'-deoxy-P-thiocytidylyl-(3'→5')-2'-deoxy-
P-thiocytidylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-deoxy-
P-thioguanylyl-(3'→5')-2'-deoxy-P-thioguanylyl-(3'→5')-2'-deoxy-
P-thiocytidylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-deoxy-
P-thiocytidylyl-(3'→5')-2'-deoxycytidine
antineoplastic

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cénersen oligonucléotide antisense inhibiteur de l'expression de p53

2'-déoxy-P-thiocytidylyl-(3'→5')-2'-déoxy-P-thiocytidylyl-(3'→5')-
2'-déoxy-P-thiocytidylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-déoxy-
P-thioguanylyl-(3'→5')-2'-déoxy-P-thiocytidylyl-(3'→5')-
P-thiothymidylyl-(3'→5')-2'-déoxy-P-thiocytidylyl-(3'→5')-2'-déoxy-
P-thiocytidylyl-(3'→5')-2'-déoxy-P-thiocytidylyl-(3'→5')-2'-déoxy-
P-thiocytidylyl-(3'→5')-2'-déoxy-P-thiocytidylyl-(3'→5')-2'-déoxy-
P-thiocytidylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-déoxy-
P-thioguanylyl-(3'→5')-2'-déoxy-P-thioguanylyl-(3'→5')-2'-déoxy-
P-thiocytidylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-déoxy-
P-thiocytidylyl-(3'→5')-2'-déoxycytidine
antinéoplasique

cenersén oligonucleótido antisentido inhibidor de la expresión de p53

2'-desoxi-P-tiocitidilil-(3'→5')-2'-desoxi-P-tiocitidilil-(3'→5')-2'-desoxi-
P-tiocitidilil-(3'→5')-P-tiotimidilil-(3'→5')-2'-desoxi-P-tioguanilil-
(3'→5')-2'-desoxi-P-tiocitidilil-(3'→5')-P-tiotimidilil-(3'→5')-2'-desoxi-
P-tiocitidilil-(3'→5')-2'-desoxi-P-tiocitidilil-(3'→5')-2'-desoxi-
P-tiocitidilil-(3'→5')-2'-desoxi-P-tiocitidilil-(3'→5')-2'-desoxi-
P-tiocitidilil-(3'→5')-2'-desoxi-P-tiocitidilil-(3'→5')-P-tiotimidilil-
(3'→5')-2'-desoxi-P-tioguanilil-(3'→5')-2'-desoxi-P-tioguanilil-
(3'→5')-2'-desoxi-P-tiocitidilil-(3'→5')-P-tiotimidilil-(3'→5')-2'-desoxi-
P-tiocitidilil-(3'→5')-2'-desoxicitidina
antineoplásico

C187H226N62O103P19S19 872847-66-0

cholini fenofibratum
choline fenofibrate 2-hydroxy-N,N,N-trimethylethanaminium 2-[4-(4-chlorobenzoyl)=
phenoxy]-2-methylpropanoate
antihyperlipidaemic

fénofibrate de choline 2-[4-(4-chlorobenzoyl)phénoxy]-2-méthylpropanoate de 2-hydroxy-

N,N,N-triméthyléthanaminium
antihyperlipidémiant

fenofibrato de colina 2-[4-(4-clorobenzoil)fenoxi]-2-metilpropanoato de 2-hidroxi-

N,N,N-trimetiletanaminio
antihiperlipémico
+ -
C5H14NO .C17H14ClO4 856676-23-8

Cl O CO2-
H3C
CH3
N+ H3C CH3
HO CH3
O

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cinaciguatum
cinaciguat 4-({(4-carboxybutyl)[2-(2-{[4-(2-phenylethyl)phenyl]methoxy}phenyl)=
ethyl]amino}methyl)benzoic acid
guanylate cyclase activator

cinaciguat acide 4-({(4-carboxybutyl)[2-(2-{[4-(2-phényléthyl)phényl]méthoxy}=

phényl)éthyl]amino}méthyl)benzoïque
activateur de la guanylate cyclase

cinaciguat ácido 4-({(4-carboxibutil)[2-(2-{[4-(2-feniletil)fenil]metoxi}fenil)=

etil]amino}metil)benzoico
activador de la guanilato ciclasa

C36H39NO5 329773-35-5

CO2H

O
N
CO2H

contusugenum ladenovecum*
contusugene ladenovec
(Recombinant) replication restricted adenovirus (type 5) vector, E1
deleted, partial E3 deletion, containing/expressing a wild type p53
gene driven by a cytomegalovirus promoter
induce cell growth arrest and apotopsis

contusugène ladénovec Vecteur adénovirus (type 5) recombinant défectif, délété de E1 et

partiellement de E3, contenant le gène p53 sauvage sous le contrôle
du promoteur cytomégalovirus
induit l'arrêt de la croissance cellulaire et l'apoptose

contusugén ladenovec Vector adenovirus (tipo 5) recombinante defectivo, con deleción de

E1 y parcialmente de E3, que contiene el gen p53 salvaje controlado
por el promotor de cytomegalovirus
induce la detención del crecimiento celular y la apoptosis

600735-73-7

dapagliflozinum
dapagliflozin (1S)-1,5-anhydro-1-C-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-
D-glucitol
antidiabetic

dapagliflozine (1S)-1,5-anhydro-1-C-{4-chloro-3-[(4-éhoxyphényl)méthyl]phényl}-
D-glucitol
antidiabétique

dapagliflozina (1S)-1,5-anhidro-1-C-{4-cloro-3-[(4-etoxifenil)metil]fenil}-D-glucitol
hipoglucemiante

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C21H25ClO6 461432-26-8

O CH3

Cl

HO

O
OH
HO
OH

delimotecanum
delimotecan poly{[2-O-(carboxymethyl)-α-D-glucopyranosyl-(1→6)]-co-[2-O-(15-
{[(4S)-4,11-diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-
1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl]oxy}-2,5,8,11-
tetraoxo-3,6,9,12-tetraazapentadecyl)-α-D-glucopyranosyl-
(1→6)]-co-[α-D-glucopyranosyl-(1→6)]}
antineoplastic

délimotécan poly{[2-O-(carboxyméthyl)-α-D-glucopyranosyl-(1→6)]-co-[2-O-(15-
{[(4S)-4,11-diéthyl-4-hydroxy-3,14-dioxo-3,4,12,14-tétrahydro-
1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoléin-9-yl]oxy}-2,5,8,11-
tétraoxo-3,6,9,12-tétraazapentadécyl)-α-D-glucopyranosyl-(1→6)]-
co-[α-D-glucopyranosyl-(1→6)]}
antinéoplasique

delimotecán poli{[2-O-(carboximetil)-α-D-glucopiranosil-(1→6)]-co-[2-O-(15-{[(4S)-
4,11-dietil-4-hidroxi-3,14-dioxo-3,4,12,14-tetrahidro-
1H-pirano[3',4':6,7]indolizino[1,2-b]quinolin-9-il]oxi}-2,5,8,11-
tetraoxo-3,6,9,12-tetraazapentadecil)-α-D-glucopiranosil-(1→6)]-
co-[α-D-glucopiranosil-(1→6)]}
antineoplásico

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[C39H46N6O14[C6H10O5]x[C8H12O7]y]n 187852-63-7 (for Na salt)

HO
O
OH
HO O
OH x
O
CH3
O
O
OH OH
O HO O
N HO2C O
y
O
N
OH
H3C
HO O
H
O
O
H H
O N N
N N O
H H
O O n

dovitinibum
dovitinib 4-amino-5-fluoro-3-[6-(4-methylpiperazin-1-yl)-1H-benzimidazole-
2-yl]quinolin-2(1H)-one
antineoplastic

dovitinib 4-amino-5-fluoro-3-[6-(4-méthylpipérazin-1-yl)-1H-benzimidazol-
2-yl]quinoléin-2(1H)-one
antinéoplasique

dovitinib 4-amino-5-fluoro-3-[6-(4-metilpiperazin-1-il)-1H-benzoimidazol-
2-il]quinolin-2(1H)-ona
antineoplásico

C21H21FN6O 405169-16-6

O N N N CH3

HN N
H
NH2

eldecalcitolum
eldecalcitol (5Z,7E)-2β-(3-hydroxypropoxy)-9,10-secocholesta-5,7,10(19)-triene-
1α,3β,25-triol
vitamin D analogue

eldécalcitol (5Z,7E)-2β-(3-hydroxypropoxy)-9,10-sécocholesta-5,7,10(19)-triène-
1α,3β,25-triol
analogue de la vitamine D

eldecalcitol (5Z,7E)-2β-(3-hidroxipropoxi)-9,10-secocolesta-5,7,10(19)-trieno-
1α,3β,25-triol
análogo de la vitamina D

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C30H50O5 104121-92-8

H3 C H
CH3 CH3
H
CH3
HO

CH2

HO OH
H H
HO O H

elvitegravirum
elvitegravir 6-[(3-chloro-2-fluorophenyl)methyl]-1-[(2S)-1-hydroxy-3-methylbutan-
2-yl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
antiviral

elvitégravir acide 6-[(3-chloro-2-fluorophényl)méthyl]-1-[(2S)-1-hydroxy-

3-méthylbutan-2-yl]-7-méthoxy-4-oxo-1,4-dihydroquinoline-
3-carboxylique
antiviral

elvitegravir ácido 6-[(3-cloro-2-fluorofenil)metil]-1-[(2S)-1-hidroxi-3-metilbutan-

2-il]-7-metoxi-4-oxo-1,4-dihidroquinolina-3-carboxílico
antiviral

C23H23ClFNO5 697761-98-1

CH3
HO
CH3 H CH3
O N

Cl CO2H
F O

epetirimodum
epetirimod 1-(2-methylpropyl)-1H-imidazo[4,5-c][1,5]naphthyridin-4-amine
immunomodulator

épétirimod 1-(2-méthylpropyl)-1H-imidazo[4,5-c][1,5]naphtyridin-4-amine
immunomodulateur

epetirimod 1-(2-metilpropil)-1H-imidazo[4,5-c][1,5]naftiridin-4-amina
inmunomodulador

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C13H15N5 227318-71-0

H3C

H3C N
N N

N NH2

epoetinum kappa
epoetin kappa 1-165-erythropoietin (human JR-013), glycoform κ
antianaemic

époétine kappa érythropoïétine (humaine JR-013)-(1-165), glycoforme κ

antianémique

epoetina kappa 1-165-eritropoyetina (humana JR-013), glicoforma κ

antianémico

C809H1301N229O240S5 879555-13-2

eribulinum
eribulin (2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR,13bS,15S,18S,21S,24
S,26R,28R,29aS)-2-[(2S)-3-amino-2-hydroxypropyl]-3-methoxy-
26-methyl-20,27-dimethylidenehexacosahydro-11,15:18,21:24,28-
triepoxy-7,9-ethano-12,15-methano-9H,15H-furo[3,2-i]furo[2',3':5,6]=
pyrano[4,3-b][1,4]dioxacyclopentacosin-5(4H)-one
antineoplastic

éribuline (2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR,13bS,15S,18S,21S,24
S,26R,28R,29aS)-2-[(2S)-3-amino-2-hydroxypropyl]-3-méthoxy-
26-méthyl-20,27-diméthylidènehexacosahydro-11,15:18,21:24,28-
triépoxy-7,9-éthano-12,15-méthano-9H,15H-furo[3,2-i]furo[2',3':5,6]=
pyrano[4,3-b][1,4]dioxacyclopentacosin-5(4H)-one
antinéoplasique

eribulina (2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR,13bS,15S,18S,21S,24
S,26R,28R,29aS)-2-[(2S)-3-amino-2-hidroxipropil]-26-metil-
20,27-dimetilideno-3-metoxihexacosahidro-11,15:18,21:24,28-
triepoxi-7,9-etano-12,15-metano-9H,15H-furo[3,2-i]furo[2',3':5,6]=
pirano[4,3-b][1,4]dioxaciclopentacosin-5(4H)-ona
antineoplásico

C40H59NO11 253128-41-5

H3C
O H
H
H
H2 N H
O O H H
HO H H H O
CH2 O
O H H
H
H
O O H
H CH3 O
O
H
H H

H2C

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faxeladolum
faxeladol 3-[(1R,2R)-2-(dimethylaminomethyl)cyclohexyl]phenol
analgesic

faxéladol 3-{(1R,2R)-2-[(diméthylamino)méthyl]cyclohexyl}phenol
analgésique

faxeladol 3-[(1R,2R)-2-(dimetilaminometil)ciclohexil]fenol
analgésico

C15H23NO 433265-65-7

CH3
N
CH3
H
H

OH

ferricum carboxymaltosum
ferric carboxymaltose poly[D-glucopyranosyl(1→4)]-D-gluconic acid complex of hydrated
iron(III) oxide
haematinic

carboxymaltose ferrique complexe d'oxide de fer(III) et d'acide poly[D-glucopyranosyl(1→4)]-

D-gluconique hydraté
hématinique

carboximaltosa férrica ácido poli[D-glucopiranosil(1→4)]-D-glucónico complejo de óxido de

hierro(III) hidratado
hematínico

FeIIIw([C6H10O5]aC6H11O7)x(OH)yOz.nH2O 9007-72-1

flovagatranum
flovagatran (1R)-1-{N-[(benzyloxy)carbonyl]-D-phenylalanyl-L-prolinamido}=
butylboronic acid
thrombin inhibitor

flovagatran acide (1R)-1-{N-[(benzyloxy)carbonyl]-D-phénylalanyl-L-prolinamido}

butylboronique
inhibiteur de la thrombine

flovagatrán ácido (1R)-1-{N-[(benciloxi)carbonil]-D-fenilalanil-L-prolinamido}=

butilborónico
inhibidor de la trombina

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C27H36BN3O7 871576-03-3

CH3
O
O O H
H H
O N OH
N N B
H
O H OH

gantenerumabum*
gantenerumab immunoglobulin G1, anti-(human beta-amyloid peptides Aβ42 and
Aβ40) human monoclonal antibody; gamma1 heavy chain (Homo
sapiens VH-IGHG1) (229-215’)-disulfide with kappa light chain
(Homo sapiens V-KAPPA-IGKC); (235-235”:238-238”)-bisdisulfide
ٛ oured
immunomodulator

ganténérumab immunoglobuline G1, anti-(peptides beta-amyloides Aβ42 et Aβ40

humains) anticorps monoclonal humain; chaîne lourde gamma1
(Homo sapiens VH-IGHG1) (229-215’)-disulfure avec la chaîne
légère kappa (Homo sapiens V-KAPPA-IGKC); dimère
(235-235”:238-238”)-bisdisulfure
immunomodulateur

gantenerumab inmunoglobulina G1, anticuerpo monoclonal humano anti-(péptidos

beta-amiloides Aβ42 et Aβ40 humanos); cadena pesada gamma1
(Homo sapiens VH-IGHG1) (229-215’)-disulfuro con la cadena ligera
kappa (Homo sapiens V-KAPPA-IGKC); dimero (235-235”:238-
238”)-bisdisulfuro
inmunomodulador

89957-37-9
γ1- heavy chain / Chaîne lourde γ1 / Cadena pesada γ1

QVELVESGGG LVQPGGSLRL SCAASGFTFS SYAMSWVRQA PGKGLEWVSA 50

INASGTRTYY ADSVKGRFTI SRDNSKNTLY LQMNSLRAED TAVYYCARGK 100
GNTHKPYGYV RYFDVWGQGT LVTVSSASTK GPSVFPLAPS SKSTSGGTAA 150
LGCLVKDYFP EPVTVSWNSG ALTSGVHTFP AVLQSSGLYS LSSVVTVPSS 200
SLGTQTYICN VNHKPSNTKV DKKVEPKSCD KTHTCPPCPA PELLGGPSVF 250
LFPPKPKDTL MISRTPEVTC VVVDVSHEDP EVKFNWYVDG VEVHNAKTKP 300
REEQYNSTYR VVSVLTVLHQ DWLNGKEYKC KVSNKALPAP IEKTISKAKG 350
QPREPQVYTL PPSRDELTKN QVSLTCLVKG FYPSDIAVEW ESNGQPENNY 400
KTTPPVLDSD GSFFLYSKLT VDKSRWQQGN VFSCSVMHEA LHNHYTQKSL 450
SLSPGK 456

κ-light chain / Chaîne légère κ / Cadena ligera κ

DIVLTQSPAT LSLSPGERAT LSCRASQSVS SSYLAWYQQK PGQAPRLLIY 50

GASSRATGVP ARFSGSGSGT DFTLTISSLE PEDFATYYCL QIYNMPITFG 100
QGTKVEIKRT VAAPSVFIFP PSDEQLKSGT ASVVCLLNNF YPREAKVQWK 150
VDNALQSGNS QESVTEQDSK DSTYSLSSTL TLSKADYEKH KVYACEVTHQ 200
GLSSPVTKSF NRGEC 215

The position of cysteine (C) residues that form disulphide bridges and asparagine residues
that are N-glycosylated are in bold.

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golotimodum
golotimod D-γ-glutamyl-L-tryptophan
immonomudulator

golotimod D-γ-glutamyl-L-tryptophane
immunomodulateur

golotimod D-γ-glutamil-L-triptófano
inmunomodulador

C16H19N3O5 229305-39-9

H NH2
H
N CO2H
HO2C
O H

N
H

ibalizumabum*
ibalizumab immunoglobulin G4, anti-(human CD4) humanized monoclonal
antibody Hu5A8 (TNX-355); gamma4 heavy chain [humanized VH
(Homo sapiens FR/Mus musculus CDR [8.8.15] from clone Mu5A8)-
Homo sapiens IGHG4*01] (136-219’)-disulfide with kappa light chain
[humanized V-KAPPA (Homo sapiens FR/Mus musculus CDR
[12.3.8] from clone Mu5A8)-Homo sapiens IGKC*01] ; (228-
228’:231-231”)-bisdisulfide dimer
antiviral

ibalizumab immunoglobuline G4, anti-(CD4 humain) anticorps monoclonal

humanisé Hu5A8 (TNX-355); chaîne lourde gamma4 [VH humanisé
(Homo sapiens FR/Mus musculus CDR [8.8.15] du clone 5A8)-Homo
sapiens IGHG4] (136-219’)-disulfure avec la chaîne légère kappa [V-
KAPPA humanisé (Homo sapiens FR/Mus musculus CDR [12.3.8]
du clone Mu5A8)-Homo sapiens IGKC*01]; dimère (228-228”:231-
231”)-bisdisulfure
antiviral

ibalizumab inmunoglobulina G4, anti-(CD4 humano) anticuerpo monoclonal

humanizado Hu5A8 (TNX-355); cadena pesada gamma4 [VH
humanizado (Homo sapiens FR/Mus musculus CDR [8.8.15] del clon
5A8)-Homo sapiens IGHG4] (136-219’)-disulfuro con la cadena
ligera kappa [V-KAPPA humanizada (Homo sapiens FR/Mus
musculus CDR [12.3.8] del clon Mu5A8)-Homo sapiens IGKC*01];
dímero (228-228”:231-231”)-bisdisulfuro
antiviral

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680188-33-4

Ig γ4-heavy chain / Chaîne lourde Ig γ4 / Cadena pesada Ig γ4

QVQLQQSGPE VVKPGASVKM SCKASGYTFT SYVIHWVRQK PGQGLDWIGY 50

INPYNDGTDY DEKFKGKATL TSDTSTSTAY MELSSLRSED TAVYYCAREK 100
DNYATGAWFA YWGQGTLVTV SSASTKGPSV FPLAPCSRST SESTAALGCL 150
VKDYFPEPVT VSWNSGALTS GVHTFPAVLQ SSGLYSLSSV VTVPSSSLGT 200
KTYTCNVDHK PSNTKVDKRV ESKYGPPCPS CPAPEFLGGP SVFLFPPKPK 250
DTLMISRTPE VTCVVVDVSQ EDPEVQFNWY VDGVEVHNAK TKPREEQFNS 300
TYRVVSVLTV LHQDWLNGKE YKCKVSNKGL PSSIEKTISK AKGQPREPQV 350
YTLPPSQEEM TKNQVSLTCL VKGFYPSDIA VEWESNGQPE NNYKTTPPVL 400
DSDGSFFLYS RLTVDKSRWQ EGNVFSCSVM HEALHNHYTQ KSLSLSLGK 449

Ig κ-light chain / Chaîne légère Ig κ / Cadena ligera Ig κ

DIVMTQSPDS LAVSLGERVT MNCKSSQSLL YSTNQKNYLA WYQQKPGQSP 50

KLLIYWASTR ESGVPDRFSG SGSGTDFTLT ISSVQAEDVA VYYCQQYYSY 100
RTFGGGTKLE IKRTVAAPSV FIFPPSDEQL KSGTASVVCL LNNFYPREAK 150
VQWKVDNALQ SGNSQESVTE QDSKDSTYSL SSTLTLSKAD YEKHKVYACE 200
VTHQGLSSPV TKSFNRGEC 219

idrabiotaparinuxum natricum
idrabiotaparinux sodium
nonasodium methyl (2-deoxy-3,4-di-O-methyl-2-{6-[5-(2-
oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)pentanamido]=
hexanamido}-6-O-sulfo-α-D-glucopyranosyl)-(1→4)-(2,3-di-O-methyl-
β-D-glucopyranosyluronate)-(1→4)-(2,3,6-tri-O-sulfo-
α-D-glucopyranoside)-(1→4)-(2,3-di-O-methyl-
α-L-idopyranosyluronate)-(1→4)-2,3,6-tri-O-sulfo-
α-D-glucopyranoside
antithrombotic

idrabiotaparinux sodique 2-déoxy-3,4-di-O-méthyl-2-{[6-({5-[(3aS,4S,6aR)-2-oxohexahydro-

1H-thiéno[3,4-d]imidazol-4-yl]pentanoyl}amino)hexanoyl]amino}-
6-O-sulfo-α-D-glucopyranosyl-(1→4)-2,3-di-O-méthyl-
β-D-glucopyranuronosyl-(1→4)-2,3,6-tri-O-sulfo-α-D-glucopyranosyl-
(1→4)-2,3-di-O-méthyl-α-L-idopyranuronosyl-(1→4)-2,3,6-tri-O-sulfo-
α-D-glucopyranoside de méthyle nonasodique
antithrombotique

idrabiotaparinux sódico 2-desoxy-3,4-di-O-metil-2-{[6-({5-[(3aS,4S,6aR)-2-oxohexahidro-

1H-tieno[3,4-d]imidazol-4-il]pentanoil}amino)hexanoil]amino}-
6-O-sulfo-α-D-glucopiranosil-(1→4)-2,3-di-O-metil-
β-D-glucopiranuronosil-(1→4)-2,3,6-tri-O-sulfo-α-D-glucopiranosil-
(1→4)-2,3-di-O-metil-α-L-idopiranuronosil-(1→4)-2,3,6-tri-O-sulfo-
α-D-glucopiranosido de metilo y nonasodico
antitrombótico

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C53H79N4Na9O51S8 405159-59-3

O
SO3Na

NaO3S O
O
SO3Na O
O
NaO3S O O O
O CO2Na CH3
SO3Na CO2Na O O
OCH3 SO3Na
O O O O
OCH3 OCH3 O
SO3Na OCH3
H3CO O
S
HN O OCH3
H
H
H NH
N O
H HN

laropiprantum
laropiprant [(3R)-4-[(4-chlorophenyl)methyl]-7-fluoro-5-(methanesulfonyl)-
1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl]acetic acid
prostanoid DP1 receptor antagonist

laropiprant acide [(3R)-4-[(4-chlorophényl)méthyl]-7-fluoro-5-(méthanesulfonyl)-

1,2,3,4-tétrahydrocyclopenta[b]indol-3-yl]acétique
antagoniste du récepteur DP1 des prostanoïdes

laropiprant ácido [(3R)-4-[(4-clorofenil)metil]-7-fluoro-5-(metanosulfonil)-

1,2,3,4-tetrahidrociclopenta[b]indol-3-il]acético
antagonista del receptor DP1 de prostanoides

C21H19ClFNO4S 571170-77-9

F CO2H

N H

O S
CH3 Cl
O

levamlodipinum
levamlodipine 3-ethyl 5-methyl (4S)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-
6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
calcium channel blocker

lévamlodipine (4S)-2-[(2-aminoéthoxy)méthyl]-4-(2-chlorophényl)-6-méthyl-
1,4-dihydropyridine-3,5-dicarboxylate de 3-éthyle et de 5-méthyle
antagoniste des canaux calciques

levamlodipino (4S)-2-[(2-aminoetoxi)metil]-4-(2-clorofenil)-6-metil-
1,4-dihidropiridina-3,5-dicarboxilato de 3-etilo y 5-metilo
antagonista de los canales del calcio

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C20H25ClN2O5 103129-82-4

H
H3C N NH2
O
O O CH3
H3C
H
O O
Cl

lonaprisanum
lonaprisan 11β-(4-acetylphenyl)-20,20,21,21,21-pentafluoro-17-hydroxy-19-nor-
17α-pregna-5,9-dien-3-one
progesterone receptor antagonist

lonaprisan 11β-(4-acétylphényl)-20,20,21,21,21-pentafluoro-17-hydroxy-19-nor-
17α-prégna-5,9-dién-3-one
antagoniste des récepteurs de la progestérone

lonaprisán 11β-(4-acetilfenil)-20,20,21,21,21-pentafluoro-17-hidroxi-19-nor-
17α-pregna-5,9-dien-3-ona
antagonista de los receptores de progesterona

C28H29F5O3 211254-73-8

H3C
H CH3 OH CF3

F
H F

H
O

metenkefalinum
metenkefalin L-tyrosylglycylglycyl-L-phenylalanyl-L-methionine
β-endorphin human-(1-5)-peptide
µ and δ opioid receptors agonist

métenkefaline L-tyrosylglycylglycyl-L-phénylalanyl-L-méthionine
β-endorphine humaine-(1-5)-peptide
agoniste des récepteurs opioïdes µ et δ

metencefalina L-tirosilglicilglicil-L-fenilalanil-L-metionina
β-endorfina humana-(1-5)-peptido
agonista de los receptores µ y δ de opiáceos

C27H35N5O7S 58569-55-4

H L -Tyr Gly Gly L -Phe L-Met OH

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milveterolum
milveterol N-{2-hydroxy-5-[(1R)-1-hydroxy-2-{[2-(4-{[(2R)-2-hydroxy-
2-phenylethyl]amino}phenyl)ethyl]amino}ethyl]phenyl}formamide
bronchodilator

milvétérol N-{2-hydroxy-5-[(1R)-1-hydroxy-2-{[2-(4-{[(2R)-2-hydroxy-
2-phényléthyl]amino}phényl)éthyl]amino}éthyl]phényl}formamide
bronchodilatateur

milveterol N-{2-hidroxi-5-[(1R)-1-hidroxi-2-{[2-(4-{[(2R)-2-hidroxi-
2-feniletil]amino}fenil)etil]amino}etil]fenil}formamida
broncodilatador

C25H29N3O4 652990-07-3

H OH
H
N

HO N
H
HN H H OH

motesanibum
motesanib N-(3,3-dimethyl-2,3-dihydro-1H-indol-6-yl)-2-{[(pyridin-4-yl)methyl]=
amino}pyridine-3-carboxamide
antineoplastic

motésanib N-(3,3-diméthyl-2,3-dihydro-1H-indol-6-yl)-2-{[(pyridin-4-yl)méthyl]=
amino}pyridine-3-carboxamide
antinéoplasique

motesanib N-(3,3-dimetil-2,3-dihidro-1H-indol-6-il)-2-{[(piridin-4-il)metil]=
amino}piridina-3-carboxamida
antineoplásico

C22H23N5O 453562-69-1

HN
CH3
NH O CH3
N
N N
H

nepiderminum
nepidermin human epidermal growth factor, recombinant DNA origin
epidermal growth factor

népidermine facteur humain de croissance épidermique, origine ADN

recombinant
facteur de croissance épidermique

nepidermina factor de crecimiento epidérmico humano; origen: ADN

recombinante
factor de crecimiento epidérmico

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C270H401N73O83S7 62253-63-8

H Asn Ser Asp Ser Glu Cys Pro Leu Ser His Asp Gly Tyr Cys
10

Leu His Asp Gly Val Cys Met Tyr Ile Glu Ala Leu Asp Lys
20

Tyr Ala Cys Asn Cys Val Val Gly Tyr Ile Gly Glu Arg Cys
30 40

Gln Tyr Arg Asp Leu Lys Trp Trp Glu Leu Arg OH
50

neratinibum
neratinib (2E)-N-[4-({3-chloro-4-[(pyridin-2-yl)methoxy]phenyl}amino)-3-cyano-
7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide
antineoplastic

nératinib (2E)-N-[4-({3-chloro-4-[(pyridin-2-yl)méthoxy]phényl}amino)-3-cyano-
7-éthoxyquinoléin-6-yl]-4-(diméthylamino)but-2-énamide
antinéoplasique

neratinib (2E)-N-[4-({3-cloro-4-[(piridin-2-yi)metoxi]fenil}amino)-3-ciano-
7-etoxiquinolin-6-il]-4-(dimetilamino)but-2-enamida
antineoplásico

C30H29ClN6O3 698387-09-6

H3 C O N

CH3 HN CN
N HN Cl
H 3C O

O
N

perampanelum
perampanel 2-(6'-oxo-1'-phenyl-1',6'-dihydro[2,3'-bipyridin]-5'-yl)benzonitrile
AMPA receptor antagonist

pérampanel 2-(6'-oxo-1'-phenyl-1',6'-dihydro[2,3'-bipyridin]-5'-yl)benzonitrile
antagoniste des récepteurs de l'AMPA

perampanel 2-(1'-fenil-6'-oxo-1',6'-dihidro[2,3'-bipiridin]-5'-il)benzonitrilo
antagonista de los receptores del AMPA

C23H15N3O 380917-97-5

N
CN

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peretinoinum
peretinoin (2E,4E,6E,10E)-3,7,11,15-tetramethylhexadeca-2,4,6,10,14-
pentaenoic acid
retinoid derivative, antineoplastic

pérétinoin acide (2E,4E,6E,10E)-3,7,11,15-tétraméthylhexadéca-2,4,6,10,14-

penténoïque
rétinoïde, antinéoplasique

peretinoína ácido (2E,4E,6E,10E)-3,7,11,15-tetrametilhexadeca-2,4,6,10,14-

pentaenoico
retinoide, antineoplásico

C20H30O2 81485-25-8

CH3 CH3 CH3 CH3

CO2H
H 3C

pexacerfontum
pexacerfont N-[(2R)-butan-2-yl]-8-(6-methoxy-2-methylpyridin-3-yl)-
2,7-dimethylpyrazolo[1,5-a][1,3,5]triazin-4-amine
antidepressant

pexacerfont N-[(2R)-butan-2-yl]-8-(6-méthoxy-2-méthylpyridin-3-yl)-
2,7-diméthylpyrazolo[1,5-a][1,3,5]triazin-4-amine
antidépresseur

pexacerfont N-[(2R)-butan-2-il]-8-(6-metoxi-2-metilpiridin-3-il)-
2,7-dimetilpirazolo[1,5-a][1,3,5]triazin-4-amina
antidepresivo

C18H24N6O 459856-18-9

CH3
H3C H N
N
N
H3C
H
N
N
H3C N OCH3
H3C

pimavanserinum
pimavanserin 1-[(4-fluorophenyl)methyl]-1-(1-methylpiperidin-4-yl)-
3-{[4-(2-methylpropoxy)phenyl]methyl}urea
serotonin receptor antagonist

pimavansérine 1-[(4-fluorophényl)méthyl]-1-(1-méthylpipéridin-4-yl)-
3-{[4-(2-méthylpropoxy)phényl]méthyl}urée
antagoniste des récepteurs de la sérotonine

pimavanserina 1-[(4-fluorofenil)metil]-1-(1-metilpiperidin-4-il)-
3-{[4-(2-metilpropoxi)fenil]metil}urea
antagonista del receptor de la serotonina

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C25H34FN3O2 706779-91-1

CH3
N
CH3
F O
CH3
H
N N

piragliatinum
piragliatin (2R)-2-[3-chloro-4-(methanesulfonyl)phenyl]-
3-[(1R)-3-oxocyclopentyl]-N-(pyrazin-2-yl)propanamide
antidiabetic

piragliatine (2R)-2-[3-chloro-4-(méthanesulfonyl)phényl]-
3-[(1R)-3-oxocyclopentyl]-N-(pyrazin-2-yl)propanamide
antidiabétique

piragliatina (2R)-2-[3-cloro-4-(metanosulfonil)fenil]-3-[(1R)-3-oxociclopentil]-
N-(pirazin-2-il)propanamida
hipoglucemiante

C19H20ClN3O4S 625114-41-2

O O
S N
H3 C O

Cl N N
H
H
H
O

pomalidomidum
pomalidomide 4-amino-2-[(3RS)-2,6-dioxopiperidin-3-yl]-2H-isoindole-1,3-dione
antineoplastic

pomalidomide 4-amino-2-[(3RS)-2,6-dioxopipéridin-3-yl]-2H-isoindole-1,3-dione
antinéoplasique

pomalidomida 4-amino-2-[(3RS)-2,6-dioxopiperidin-3-il]-2H-isoindol-1,3-diona
antineoplásico

C13H11N3O4 19171-19-8

O O
and enantiomer
N NH et énantiomère
H y enantiómero
O O
NH2

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posaraprostum
posaraprost propan-2-yl (5Z)-7-{(1R,2S)-2-[(1E,3S)-3-hydroxy-5-phenylpent-
1-en-1-yl]-5-oxocyclopent-3-en-1-yl}hept-5-enoate
anti-inflammatory

posaraprost (5Z)-7-{(1R,2S)-2-[(1E,3S)-3-hydroxy-5-phénylpent-1-én-1-yl]-
5-oxocyclopent-3-én-1-yl}hept-5-énoate de propan-2-yle
anti-inflammatoire

posaraprost (5Z)-7-{(1R,2S)-2-[(1E,3S)-3-hidroxi-5-fenilpent-1-en-1-il]-
5-oxociclopent-3-en-1-ilo}-hept-5-enoato de propan-2-ilo
antiinflamatorio

C26H34O4 172740-14-6

O H
O CH3

O CH3
H
H OH

pyronaridinum
pyronaridine 4-[(7-chloro-2-methoxybenzo[b][1,5]naphthyridin-10-yl)amino]-
2,6-bis[(pyrrolidin-1-yl)methyl]phenol
antimalarial

pyronaridine 4-[(7-chloro-2-méthoxybenzo[b][1,5]naphthyridin-10-yl)amino]-
2,6-bis[(pyrrolidin-1-yl)méthyl]phénol
antipaludique

pironaridina 4-[(7-cloro-2-metoxibenzo[b][1,5]naftiridin-10-il)amino]-
2,6-bis[(pirrolidin-1-il)metil]fenol
antipalúdico

C29H32ClN5O2 74847-35-1

N Cl

H3CO N
HN
N

OH

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rabeximod
rabeximod 2-(9-chloro-2,3-dimethyl-6H-indolo[2,3-b]quinoxalin-6-yl)-
N-[2-(dimethylamino)ethyl]acetamide
immunomodulator

rabeximod 2-(9-chloro-2,3-diméthyl-6H-indolo[2,3-b]quinoxalin-6-yl)-
N-[2-(diméthylamino)éthyl]acétamide
immunomodulateur

rabeximod 2-(9-cloro-2,3-dimetil-6H-indolo[2,3-b]quinoxalin-6-il)-
N-[2-(dimetilamino)etil]acetamida
inmunomodulador

C22H24ClN5O 872178-65-9

CH3
Cl
N
CH3
N
N
H
N CH3
N
O CH3

raltegravirum
raltegravir N-[(4-fluorophenyl)methyl]-5-hydroxy-1-methyl-2-[2-(5-methyl-
1,3,4-oxadiazole-2-carboxamido)propan-2-yl]-6-oxo-
1,6-dihydropyrimidine-4-carboxamide
antiviral

raltégravir N-[(4-fluorophényl)méthyl]-5-hydroxy-1-méthyl-2-[2-(5-méthyl-
1,3,4-oxadiazole-2-carboxamido)propan-2-yl]-6-oxo-
1,6-dihydropyrimidine-4-carboxamide
antiviral

raltegravir N-[(4-fluorofenil)metil]-5-hidroxi-1-metil-2-[2-(5-metil-1,3,4-oxadiazol-
2-carboxamido)propan-2-il]-6-oxo-1,6-dihidropirimidina-
4-carboxamida
antiviral

C20H21FN6O5 518048-05-0

O H3 C CH3 O
O N
H3 C N N
H H
N N N
H3 C OH F
O

regrelorum
regrelor N6-(N-ethylcarbamoyl)-2',3'-O-[(1S,2E)-3-phenylprop-2-ene-1,1-diyl]-
5'-adenylic acid
platelet aggregation inhibitor

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régrélor acide N6-(N-éthylcarbamoyl)-2',3'-O-[(1S,2E)-3-phénylprop-2-ène-

1,1-diyl]-5'-adénylique
antiagrégant plaquettaire

regrelor ácido N6-(N-etilcarbamoil)-2',3'-O-[(1S,2E)-3-fenilprop-2-eno-

1,1-diilo]-5'-adenílico
inhibidor de la agregacion plaqueteria

C22H25N6O8P 787548-03-2

H3C N NH
H
N
N

O O N N
P
O
HO OH

O O

rolapitantum
rolapitant (5S,8S)-8-({(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy}methyl)-
8-phenyl-1,7-diazaspiro[4.5]decan-2-one
neurokinin NK1 receptor antagonist

rolapitant (5S,8S)-8-({(1R)-1-[3,5-bis(trifluorométhyl)phényl]éthoxy}méthyl)-
8-phényl-1,7-diazaspiro[4.5]décan-2-one
antagoniste du récepteur NK1 de la neurokinine

rolapitant (5S,8S)-8-({(1R)-1-[3,5-bis(trifluorometil)fenil]etoxi}metil)-8-fenil-
1,7-diazaspiro[4.5]decan-2-ona
antagonista del receptor NK1 de neurokinina

C25H26F6N2O2 552292-08-7

HN CF3

NH
O
CF3
H CH3

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romiplostimum*
romiplostim L-methionyl[human immunogloblin heavy constant gamma 1-(227
C-terminal residues)-peptide (Fc fragment)] fusion protein with 41
amino acids peptide, (7-7':10,10')-bisdisulfide dimer
platelet stimulating factor (through Mpl receptor)

romiplostim (7-7':10,10')-bisdisulfure du dimère de la protéine de fusion entre le

L-méthionyl[chaine constante gamma 1 de l’immunoglobuline
humaine-(227 aminoacides C-terminaux)-peptide (fragment Fc)] et
un peptide de 41 aminoacides
facteur de stimulation plaquettaire (par le récepteur MpI)

romiplostim (7-7':10,10')-bisdisulfuro del dímero de la proteína de fusión entre la

L-metionil[cadena constante gamma 1 de la inmunoglobulina
humana-(227 aminoácidos C-terminales)-péptido (fragmento Fc)] y
un péptido de 41 aminoácidos
factor estimulante de plaquetas (mediante el receptor Mpl)

C2634H4086N722O790S18 267639-76-9

Monomer / Monomère / Monómero

MDKTHTCPPC PAPELLGGPS VFLFPPKPKD TLMISRTPEV TCVVVDVSHE 50
DPEVKFNWYV DGVEVHNAKT KPREEQYNST YRVVSVLTVL HQDWLNGKEY 100
KCKVSNKALP APIEKTISKA KGQPREPQVY TLPPSRDELT KNQVSLTCLV 150
KGFYPSDIAV EWESNGQPEN NYKTTPPVLD SDGSFFLYSK LTVDKSRWQQ 200
GNVFSCSVMH EALHNHYTQK SLSLSPGKGG GGGIEGPTLR QWLAARAGGG 250
GGGGGIEGPT LRQWLAARA 269

Disulfide bridges location / Position des ponts disulfure / Posiciones de los puentes disulfuro
7-7' 10-10' 42-102 42'-102' 148-206 148'-206'

ronacaleretum
ronacaleret 3-{3-[(2R)-3-{[1-(2,3-dihydro-1H-inden-2-yl)-2-methylpropan-
2-yl]amino}-2-hydroxypropoxy]-4,5-difluorophenyl}propanoic acid
antagonist of the G-protein coupled calcium sensing receptor

ronacaléret acide 3-{3-[(2R)-3-{[1-(2,3-dihydro-1H-indèn-2-yl)-2-méthylpropan-

2-yl]amino}-2-hydroxypropoxy]-4,5-difluorophényl}propanoïque
antagoniste du récepteur sensible au calcium couplé à la protéine G

ronacaleret ácido3-{3-[(2R)-3-{[1-(2,3-dihidro-1H-inden-2-il)-2-metilpropan-
2-il]amino}-2-hidroxipropoxi]-4,5-difluorofenil}propanoico
antagonista del receptor sensible al calcio acoplado a proteína G

C25H31F2NO4 753449-67-1

F
F
H3C CH3

N O CO2H
H
H OH

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ropidoxuridinum
ropidoxuridine 1-(2-deoxy-β-D-erythro-pentofuranosyl)-5-iodopyrimidin-2(1H)-one
antineoplastic

ropidoxuridine 1-(2-déoxy-β-D-érythro-pentofuranosyl)-5-iodopyrimidin-2(1H)-one
antinéoplasique

ropidoxuridina 1-(2-desoxi-β-D-eritro-pentofuranosil)-5-iodopirimidin-2(1H)-ona
antineoplásico

C9H11IN2O4 093265-81-7

I
N

HO O N
O

OH

rosonabantum
rosonabant (5RS)-5-(4-chlorophenyl)-1-(2,4-dichlorophenyl)-N-(piperidin-1-yl)-
4,5-dihydro-1H-pyrazole-3-carboxamide
cannabinoid receptor antagonist

rosonabant (5RS)-5-(4-chlorophényl)-1-(2,4-dichlorophényl)-N-(pipéridin-1-yl)-
4,5-dihydro-1H-pyrazole-3-carboxamide
antagoniste des récepteurs cannabinoïdes

rosonabant (5RS)-5-(4-clorofenil)-1-(2,4-diclorofenil)-N-(piperidin-1-il)-
4,5-dihidro-1H-pirazol-3-carboxamida
antagonista del receptor de cannabinoides

C21H21Cl3N4O 861151-12-4

Cl O
N N
N N
H and enantiomer
Cl et énantiomère
H y enantiómero

Cl

salirasibum
salirasib 2-{[(2E,6E)-3,7,11-trimethyldodeca-2,6,10-trien-1-yl]sulfanyl}benzoic
acid
antineoplastic

salirasib acide 2-{[(2E,6E)-3,7,11-triméthyldodéca-2,6,10-trién-1-yl]sulfanyl}=

benzoïque
antinéoplasique

salirasib ácido 2-{[(2E,6E)-3,7,11-trimetildodeca-2,6,10-trien-1-il]sulfanil}=

benzoico
antineoplásico

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C22H30O2S 162520-00-5

CO2H
CH3 CH3 CH3

S CH3

sitimagenum ceradenovecum*
sitimagene ceradenovec
(recombinant) replication restricted adenovirus (type 5) vector, E1
and E3 deleted, containing/expressing the Herpes simplex virus
thymidine kinase (HSV-tk) gene
antineoplastic

sitimagène céradénovec Vecteur adénovirus (type 5 recombinant défectif, délété de E1 et E3,

contenant le gène thymidine kinase du virus de l’herpès simplex
(Herpes simplex virus - HSV-tk)
antinéoplasique

sitimagén ceradenovec Vector adenovirus (tipo 5 recombinante defectivo,con deleción de E1

y E3, que contiene el gen timidina kinasa del virus del herpes
simplex (Herpes simplex virus - HSV-tk)
antineoplásico

898830-54-1

sotrastaurinum
sotrastaurin 3-(1H-indol-3-yl)-4-[2-(4-methylpiperazin-1-yl)quinazolin-4-yl]-
1H-pyrrole-2,5-dione
protein kinase C inhibitor

sotrastaurine 3-(1H-indol-3-yl)-4-[2-(4-méthylpipérazin-1-yl)quinazolin-4-yl]-
1H-pyrrole-2,5-dione
inhibiteur de la protéine kinase C

sotrastaurina 3-(1H-indol-3-il)-4-[2-(4-metilpiperazin-1-il)quinazolin-4-il]-1H-pirrol-
2,5-diona
inhibidor de la proteinquinasa C

C25H22N6O2 425637-18-9

H
O N O

N
N N
H
N

N
CH3

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taranabantum
taranabant N-[(2S,3S)-4-(4-chlorophenyl)-3-(3-cyanophenyl)butan-2-yl}-
2-methyl-2-{[5-(trifluoromethyl)pyridin-2-yl]oxy}propanamide
cannabinoid receptor antagonist

taranabant N-[(2S,3S)-4-(4-chlorophényl)-3-(3-cyanophényl)butan-2-yl}-
2-méthyl-2-{[5-(trifluorométhyl)pyridin-2-yl]oxy}propanamide
antagoniste des récepteurs cannabinoïdes

taranabant N-[(2S,3S)-4-(4-clorofenil)-3-(3-cianofenil)butan-2-il}-2-metil-
2-{[5-(trifluorometil)piridin-2-il]oxi}propanamida
antagonista de los receptores de cannabinoides

C27H25ClF3N3O2 701977-09-5

H3 C H O
O CF3
NC N
H
H H3C CH3 N

Cl

tarenflurbilum
tarenflurbil (2R)-2-(2-fluoro-[1,1'-biphenyl-4-yl])propanoic acid
apoptosis regulator

tarenflurbil (2R)-2-(2-fluoro-[1,1'-biphényl-4-yl])propanoic acid

régulateur de l'apoptose

tarenflurbilo ácido (2R)-2-(2-fluoro-[1,1'-bifenil-4-il])propanoico

regulador de la apoptosis

C15H13FO2 051543-40-9

H CH3
F
CO2H

teplizumabum*
teplizumab immunoglobulin G1, anti-[human CD3 epsilon (CD3E)] humanized
monoclonal antibody MGA031 [hOKT3gamma1(Ala-Ala)]; gamma1
heavy chain 236L>A, 337L>A [humanized VH (Homo sapiens
FR/Mus musculus CDR from clone OKT3)-Homo sapiens IGHG1*01,
117L>A (CH2 1.3), 118L>A (CH2 1.2)] (222-213’)-disulfide with
kappa light chain [humanized V-KAPPA (Homo sapiens FR/Mus
musculus CDR from clone OKT3)-Homo sapiens IGKC*01] ; (228-
228”: 231-231”)-bisdisulfide dimer
immunomodulator

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téplizumab immunoglobuline G1, anti-[CD3 epsilon humain (CD3E)] anticorps

monoclonal humanisé MGA031 [hOKT3gamma1(Ala-Ala)]; chaîne
lourde gamma1 [VH humanisé (Homo sapiens FR/Mus musculus
CDR du clone OKT3)-Homo sapiens IGHG1*01, 117L >A (CH2 1.3),
118L>A (CH2 1.2)] (222-213’)-disulfure avec la chaîne légère kappa
[V-KAPPA humanisé (Homo sapiens FR/Mus musculus CDR du
clone OKT3)-Homo sapiens IGKC*01]; dimère (228-228”: 231-231”)-
bisdisulfure
immunomodulateur

teplizumab inmunoglobulina G1, anti-[CD3 epsilon humano (CD3E)] anticuerpo

monoclonal humanizado MGA031 [hOKT3gamma1(Ala-Ala)];
cadena pesada gamma1 [VH humanizada (Homo sapiens FR/Mus
musculus CDR del clon OKT3)-Homo sapiens IGHG1*01, 117L >A
(CH2 1.3) , 118L>A (CH2 1.2)] (222-213’)-disulfuro con la cadena
ligera kappa [V-KAPPA humanizada (Homo sapiens FR/Mus
musculus CDR del clon OKT3)-Homo sapiens IGKC*01]; dímero
(228-228”: 231-231”)-bisdisulfuro
inmunomodulador

C6462H9938N1738O2022S46 876387-05-2

Heavy chain / Chaîne lourde / Cadena pesada

QVQLVQSGGG VVQPGRSLRL SCKASGYTFT RYTMHWVRQA PGKGLEWIGY 50
INPSRGYTNY NQKVKDRFTI SRDNSKNTAF LQMDSLRPED TGVYFCARYY 100
DDHYCLDYWG QGTPVTVSSA STKGPSVFPL APSSKSTSGG TAALGCLVKD 150
YFPEPVTVSW NSGALTSGVH TFPAVLQSSG LYSLSSVVTV PSSSLGTQTY 200
ICNVNHKPSN TKVDKKVEPK SCDKTHTCPP CPAPEAAGGP SVFLFPPKPK 250
DTLMISRTPE VTCVVVDVSH EDPEVKFNWY VDGVEVHNAK TKPREEQYNS 300
TYRVVSVLTV LHQDWLNGKE YKCKVSNKAL PAPIEKTISK AKGQPREPQV 350
YTLPPSRDEL TKNQVSLTCL VKGFYPSDIA VEWESNGQPE NNYKTTPPVL 400
DSDGSFFLYS KLTVDKSRWQ QGNVFSCSVM HEALHNHYTQ KSLSLSPGK 449

Light chain / Chaîne légère / Cadena ligera

DIQMTQSPSS LSASVGDRVT ITCSASSSVS YMNWYQQTPG KAPKRWIYDT 50'
SKLASGVPSR FSGSGSGTDY TFTISSLQPE DIATYYCQQW SSNPFTFGQG 100'
TKLQITRTVA APSVFIFPPS DEQLKSGTAS VVCLLNNFYP REAKVQWKVD 150'
NALQSGNSQE SVTEQDSKDS TYSLSSTLTL SKADYEKHKV YACEVTHQGL 200'
SSPVTKSFNR GEC 213'

Disulfide bridges location / Position des ponts disulfure / Posiciones de los puentes disulfuro
22-96 22''-96'' 23'-87' 23'''-87''' 133'-193' 133'''-193''' 146-202 146''-202''
213'-222 213'''-222'' 228-228'' 231-231'' 263-323 263''-323'' 369-427 369''-427''

terameprocolum
terameprocol 1,1'-[(2R,3S)-2,3-dimethylbutane-1,4-diyl]bis(3,4-dimethoxybenzene)
antineoplastic

térameprocol 1,1'-[(2R,3S)-2,3-diméthylbutane-1,4-diyl]bis(3,4-diméthoxybenzène)
antinéoplasique

terameprocol 1,1'-[(2R,3S)-2,3-dimetilbutano-1,4-diil]bis(3,4-dimetoxibenceno)
antineoplásico

C22H30O4 24150-24-1

OCH3
H CH3
H3CO
OCH3
H3C H
H3CO

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thrombinum alfa*
thrombin alfa human thrombin (recombinant, glycoform α)
coagulation promoting agent

thrombine alfa thrombine humaine (recombinante, glycoforme α)

facteur de promotion de la coagulation

trombina alfa trombina humana (recombinante, glicoforma α)

factor promotor de la coagulación

C1511H2342N418O436S15 869858-13-9

Light chain / Chaîne légère / Cadena ligera

TFGSGEADCG LRPLFEKKSL EDKTERELLE SYIDGR 36

Heavy chain / Chaîne lourde / Cadena pesada

IVEG SDAEIGMSPW 50
QVMLFRKSPQ ELLCGASLIS DRWVLTAAHC LLYPPWDKNF TENDLLVRIG 100
KHSRTRYERN IEKISMLEKI YIHPRYNWRE NLDRDIALMK LKKPVAFSDY 150
IHPVCLPDRE TAASLLQAGY KGRVTGWGNL KETWTANVGK GQPSVLQVVN 200
LPIVERPVCK DSTRIRITDN MFCAGYKPDE GKRGDACEGD SGGPFVMKSP 250
FNNRWYQMGI VSWGEGCDRD GKYGFYTHVF RLKKWIQKVI DQFGE 295

Disulfide bridges location / Position des ponts disulfure / Posiciones de los puentes disulfuro
9-155 64-80 209-223 237-267

Glycosylation site / Site de glycosylation / Posición de glicosilación

Asn-89

tiliquinatinum
tiliquinatine (2R)-2-{4-[(7-bromoquinolin-2-yl)oxy]phenoxy}propanoic acid
antineoplastic

tiliquinatine acide (2R)-2-{4-[(7-bromoquinoléin-2-yl)oxy]phénoxy}propanoïque

antinéoplasique

tiliquinatina ácido (2R)-2-{4-[(7-bromoquinolin-2-il)oxi]fenoxi}propanoico

antineoplásico

C18H14BrNO4 445041-75-8

Br N O
H CH3

O CO2H

totrombopagum
totrombopag (4Z)-2-(3,4-dimethylphenyl)-4-(2-{2-hydroxy-3'-(1H-tetrazol-5-yl)
[1,1'-biphenyl-3-yl]}hydrazinylidene)-5-methyl-2,4-dihydro-
3H-pyrazol-3-one
thrombopoietin receptor agonist

totrombopag (4Z)-2-(3,4-diméthylphényl)-4-{2-[2-hydroxy-3'-(1H-tétrazol-5-yl)
[1,1'-biphényl-3-yl]]diazanylidène}-5-méthyl-2,4-dihydro-3H-pyrazol-
3-one
agoniste du récepteur de la thrombopoïétine

totrombopag (4Z)-2-(3,4-dimetilfenil)-4-{2-[2-hidroxi-3'-(1H-tetrazol-5-il)-
[1,1'-bifenil-3-il]]hidrazinilideno}-5-metil-2,4-dihidro-3H-pirazol-3-ona
agonista de los receptores de trombopoyetina

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C25H22N8O2 376592-42-6

H3C HN N
N
N
N N
N H
N OH
O

CH3
H3 C

trabedersenum
trabedersen 2'-deoxy-P-thiocytidylyl-(3'→5')-2'-deoxy-P-thioguanylyl-(3'→5')-2'-
deoxy-P-thioguanylyl-(3'→5')-2'-deoxy-P-thiocytidylyl-(3'→5')-2'-
deoxy-P-thioadenylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-deoxy-
P-thioguanylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-deoxy-
P-thiocytidylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-deoxy-
P-thioadenylyl-(3'→5')-P-thiothymidylyl-(3'→5')-P-thiothymidylyl-
(3'→5')-P-thiothymidylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-deoxy-
P-thioguanylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-deoxyadenosine
antineoplastic

trabedersen 2'-déoxy-P-thiocytidylyl-(3'→5')-2'-déoxy-P-thioguanylyl-(3'→5')-2'-
déoxy-P-thioguanylyl-(3'→5')-2'-déoxy-P-thiocytidylyl-(3'→5')-2'-
déoxy-P-thioadénylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-déoxy-
P-thioguanylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-déoxy-
P-thiocytidylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-déoxy-
P-thioadénylyl-(3'→5')-P-thiothymidylyl-(3'→5')-P-thiothymidylyl-
(3'→5')-P-thiothymidylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-déoxy-
P-thioguanylyl-(3'→5')-P-thiothymidylyl-(3'→5')-2'-déoxyadénosine
antinéoplasique

trabedersén 2'-desoxi-P-tiocitidilil-(3'→5')-2'-desoxi-P-tioguanilil-(3'→5')-2'-desoxi-
P-tioguanilil-(3'→5')-2'-desoxi-P-tiocitidilil-(3'→5')-2'-desoxi-
P-tioadenilil-(3'→5')-P-tiotimidilil-(3'→5')-2'-desoxi-P-tioguanilil-
(3'→5')-P-tiotimidilil-(3'→5')-2'-desoxi-P-tiocitidilil-(3'→5')-
P-tiotimidilil-(3'→5')-2'-desoxi-P-tioadenilil-(3'→5')-P-tiotimidilil-
(3'→5')-P-tiotimidilil-(3'→5')-P-tiotimidilil-(3'→5')-P-tiotimidilil-(3'→5')-
2'-desoxi-P-tioguanilil-(3'→5')-P-tiotimidilil-(3'→5')-2'-
desoxiadenosina
antineoplásico

C177H225N60O94P17S17 925681-61-4

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trelanserinum
trelanserin 2-(7-fluoro-2-oxo-4-{2-[4-(thieno[3,2-c]pyridin-4-yl)piperazin-
1-yl]ethyl}-1,2-dihydroquinolin-1-yl)acetamide
serotonin receptor antagonist

trélansérine 2-(7-fluoro-2-oxo-4-{2-[4-(thiéno[3,2-c]pyridin-4-yl)pipérazin-
1-yl]éthyl}-1,2-dihydroquinolein-1-yl)acétamide
antagoniste des récepteurs de la sérotonine

trelanserina 2-(7-fluoro-2-oxo-4-{2-[4-(tieno[3,2-c]piridin-4-il)piperazin-1-il]etil}-
1,2-dihidroquinolin-1-il)acetamida
antagonista de los receptores de serotonina

C24H24FN5O2S 189003-92-7

O
H2N
N
O
N
N N
F

tridecactidum*
tridecactide alpha-1-13-corticotropin, human
L-seryl-L-tyrosyl-L-seryl-L-methionyl-L-glutamyl-L-histidyl-
L-phenylalanyl-L-arginyl-L-tryptophylglycyl-L-lysyl-L-prolyl-L-valine
corticotropin-like activity

tridécactide alpha-1-13-corticotropine, humaine

L-séryl-L-tyrosyl-L-séryl-L-méthionyl-L-glutamyl-L-histidyl-
L-phénylalanyl-L-arginyl-L-tryptophylglycyl-L-lysyl-L-prolyl-L-valine
activité corticotrope

tridecactida alfa-1-13-corticotropina, humana

L-seril-L-tirosil-L-seril-L-metionil-L-glutamil-L-histidil-L-fenilalanil-
L-arginil-L-triptofilglicil-L-lisil-L-prolil-L-valina
actividad corticotropa

C75H106N20O19S 22006-64-0

H Ser Tyr Ser Met Glu His Phe Arg Trp Gly Lys Pro Val OH
10

tropantiolum
tropantiol 2-({[(1R,2R,3S,5S)-3-(4-chlorophenyl)-8-methyl-8-azabicyclo[3.2.1]
octan-2-yl]methyl}{2-[(2-sulfanylethyl)amino]ethyl}amino)ethanethiol
chelating agent

tropantiol 2-({[(1R,2R,3S,5S)-3-(4-chlorophényl)-8-méthyl-8-azabicyclo[3.2.1]
octan-2-yl]méthyl}{2-[(2-sulfanyléthyl)amino]éthyl}amino)éthanethiol
chélateur

tropantiol 2-({[(1R,2R,3S,5S)-3-(4-clorofenil)- 8-azabiciclo[ 3.2.1]octan-

2-il]metil}{2-[(2-sulfaniletil)amino]etil}amino)etanotiol
quelante

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C21H34ClN3S2 189950-11-6

Cl H

N CH3
H

H H
N SH
HS N
H

vatreptacogum alfa (activated)*

vatreptacog alfa (activated) [158-aspartic acid, 296-valine, 298-glutamine]human coagulation
factor VII activated, recombinant DNA origin
blood coagulation factor

vatreptacog alfa (activé) [158-acide aspartique, 296-valine, 298-glutamine]facteur de

coagulation VII humain activé, origine ADN recombinant
facteur de coagulation sanguine

vatreptacog alfa (activada) [158-ácido aspártico, 296-valina, 298-glutamina]factor de

coagulación VII humano activado ; origen ADN recombinante
factor de coagulación sanguínea

C1981H3051N561O620S27 897936-89-9

Light chain / Chaîne légère / Cadena ligera

ANAFLEELRP GSLERECKEE QCSFEEAREI FKDAERTKLF WISYSDGDQC 50
ASSPCQNGGS CKDQLQSYIC FCLPAFEGRN CETHKDDQLI CVNENGGCEQ 100
YCSDHTGTKR SCRCHEGYSL LADGVSCTPT VEYPCGKIPI LEKRNASKPQ 150
GR 152
Heavy chain / Chaîne lourde / Cadena pesada
IVGGKDCP KGECPWQVLL LVNGAQLCGG TLINTIWVVS AAHCFDKIKN 200
WRNLIAVLGE HDLSEHDGDE QSRRVAQVII PSTYVPGTTN HDIALLRLHQ 250
PVVLTDHVVP LCLPERTFSE RTLAFVRFSL VSGWGQLLDR GATALVLQVL 300
NVPRLMTQDC LQQSRKVGDS PNITEYMFCA GYSDGSKDSC KGDSGGPHAT 350
HYRGTWYLTG IVSWGQGCAT VGHFGVYTRV SQYIEWLQKL MRSEPRPGVL 400
LRAPFP 406
Modified residues / Résidus modifiés / Residuos modificados H NH2
E HO2C H NH2 D HO2C
6-7-14-16-19-20-25-26-29-35 63 CO2H
4-carboxyGlu 3-hydroxyAsp
HO2C CO2H OH

Disulfide bridges location / Position des ponts disulfure / Posiciones de los puentes disulfuro
17-22 50-61 55-70 72-81 91-102 98-112
114-127 135-262 159-164 178-194 310-329 340-368

Glycosylation sites / Sites de glycosylation / Posiciones de glicosilación

Ser-52 Ser-60 Asn-145 Asn-322

velimogenum aliplasmidum*
velimogene aliplasmid plasmid DNA vector, expressing HLA-B7 and beta-2 microglobulin,
driven by a Rous sarcoma virus promoter
stimulates destruction of melanoma cells

vélimogène aliplasmide vecteur ADN plasmidique, contenant les gènes HLA-B7 et beta2-
microglobuline, sous le contrôle du promoteur virus de sarcome de
Rous
stimule la destruction des cellules mélaniques

velimogén aliplásmido vector ADN de plásmído, que contiene los genes HLA-B7 y beta2-
microglobulina, controlado por el promotor de virus del sarcoma de
Rous
estimula la destrucción de las células del melanoma

296251-72-4

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voclosporinum
voclosporin 1,11-anhydro[L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-
N-methyl-L-valyl-[(2S,3R,4R,6E)-3-hydroxy-4-methyl-
2-(methylamino)nona-6,8-dienoyl][(2S)-2-aminobutanoyl]-
N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucine]
immunosuppressant

voclosporine 1,11anhydro{L-alanyl-D-alanyl-N-méthyl-L-leucyl-N-méthyl-L-leucyl-
N-méthyl-L-valyl-[(2S,3R,4R,6E)-3-hydroxy-4-méthyl-
2-(méthylamino)nona-6,8-diénoyl]-(2S)-2-aminobutanoyl-
N-méthylglycyl-N-méthyl-L-leucyl-L-valyl-N-méthyl-L-leucyl]
immunosuppresseur

voclosporina 1,11-anhidro[L-alanil-D-alanil-N-metil-L-leucil-N-metil-L-leucil-N-metil-
L-valil-[(2S,3R,4R,6E)-3-hidroxi-4-metil-2-(metilamino)nona-
6,8-dienoil][(2S)-2-aminobutanoil]-N-metilglicil-N-metil-L-leucil-L-valil-
N-methyl-L-leucina]
inmunosupresor

C63H111N11O12 515814-01-4

CH2

CH3 H3C
CH3 H CH3
OH
H3 C H3C H H H
H H CH3
H3 C
N N N N N
H
O CH3 O CH3 O O
H3 C O O
H CH3 H3C N
CH3
H3 C N O O H3C O
H H H H
N N N N CH3
O
O
H3C H H CH3 H H CH3
H3 C H3C
CH3

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AMENDMENTS TO PREVIOUS LISTS

MODIFICATIONS APPORTÉES AUX LISTES ANTÉRIEURES
MODIFICACIONES A LAS LISTAS ANTERIORES

Proposed International Non Proprietary Names (Prop. INN): List 31

(WHO Chronicle, Vol. 28, No. 3, 1974)

p. 22 dimemorfanum
dimemorfan replace graphic formula by the following

CH3
H N

H3C

Dénominations communes internationales proposées (DCI Prop.): Liste 31

(Chronique OMS, Vol. 28, No. 3, 1974)

p. 22 dimemorfanum
dimémorfane remplacer la formule développée par la suivante

CH3
H N

H3C

Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 31

(Crónica de la OMS, Vol. 28, No. 3, 1974)

p. 23 dimemorfanum
dimemorfano sustitúyase la formúla désarollada por la siguiente

CH3
H N

H3C

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Proposed INN: List 97 WHO Drug Information, Vol. 21, No. 2, 2007

Proposed International Non Proprietary Names (Prop. INN): List 71

Dénominations communes internationales proposées (DCI Prop.): Liste 71
Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 71
(WHO Drug Information, Vol. 8, No. 2, 1994)

p. 26 suprimáse insértese
afovirseno afovirsén

Proposed International Non Proprietary Names (Prop. INN): List 75

Dénominations communes internationales proposées (DCI Prop.): Liste 75
Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 75
(WHO Drug Information, Vol. 10, No. 2, 1996)

p. 100 suprimáse insértese

fomivirseno fomivirsén

Proposed International Non Proprietary Names (Prop. INN): List 77

Dénominations communes internationales proposées (DCI Prop.): Liste 77
Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 77
(WHO Drug Information, Vol. 11, No. 2, 1997)

p. 102 suprimáse insértese

trecovirseno trecovirsén

Proposed International Non Proprietary Names (Prop. INN): List 80

Dénominations communes internationales proposées (DCI Prop.): Liste 80
Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 80
(WHO Drug Information, Vol. 12, No. 4, 1998)

p. 276 solimastatum
solimastat insert the following CAS
solimastat insérer le numéro de CAS suivant
solimastat insértese el nombre del CAS siguiente
226072-63-5

Proposed International Non Proprietary Names (Prop. INN): List 81

Dénominations communes internationales proposées (DCI Prop.): Liste 81
Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 81
(WHO Drug Information, Vol. 13, No. 2, 1999)

p. 117 ganstigminum
ganstigmine insert the following CAS
ganstigmine insérer le numéro de CAS suivant
ganstigmina insértese el nombre del CAS siguiente
457075-21-7

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WHO Drug Information, Vol. 21, No. 2, 2007 Proposed INN: List 97

Proposed International Non Proprietary Names (Prop. INN): List 82

Dénominations communes internationales proposées (DCI Prop.): Liste 82
Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 82
(WHO Drug Information, Vol. 14, No. 4, 1999)

p. 268 cangrelorum
cangrelor insert the following CAS number
cangrélor insérer le numéro de CAS suivant
cangrelor insértese el nombre del CAS siguiente
163706-06-7

p. 270 crobenetinum
crobenetine insert the following CAS
crobénétine insérer le numéro de CAS suivant
crobenetina insértese el nombre del CAS siguiente
221019-25-6

p. 273 epitumomabum
epitumomab insert the following CAS
épitumomab insérer le numéro de CAS suivant
epitumomab insértese el nombre del CAS siguiente
263547-71-3

p. 277 figopitantum
figopitant insert the following CAS
figopitant insérer le numéro de CAS suivant
figopitant insértese el nombre del CAS siguiente
502422-74-4

p. 288 sulamserodum
sulamserod insert the following CAS
sulamsérod insérer le numéro de CAS suivant
sulamserod insértese el nombre del CAS siguiente
219757-90-1

Proposed International Non Proprietary Names (Prop. INN): List 85

Dénominations communes internationales proposées (DCI Prop.): Liste 85
Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 85
(WHO Drug Information, Vol. 15, No. 2, 2001)

p. 98 suprimáse insértese
alicaforseno alicaforsén

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Proposed INN: List 97 WHO Drug Information, Vol. 21, No. 2, 2007

p. 121 pralnacasanum
pralnacasan replace the action and use by the following
pralnacasan remplacer les proprietés et indications par les suivantes
pralnacasán sustitúyase el acción y uso por los siguientes

caspase inhibitor
inhibiteur de la caspase
inhibidor de la caspasa

Proposed International Non Proprietary Names (Prop. INN): List 86

Dénominations communes internationales proposées (DCI Prop.): Liste 86
Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 86
(WHO Drug Information, Vol. 16, No. 1, 2002)

p. 65 ozogamicinum
ozogamicin insert the following CAS
ozogamicine insérer le numéro de CAS suivant
ozogamicina insértese el nombre del CAS siguiente
400046-53-9

p. 70 zoticasonum
zoticasone insert the following CAS
zoticasone insérer le numéro de CAS suivant
zoticasona insértese el nombre del CAS siguiente
678160-57-1

Proposed International Non Proprietary Names (Prop. INN): List 87

Dénominations communes internationales proposées (DCI Prop.): Liste 87
Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 87
(WHO Drug Information, Vol. 16, No. 2, 2002)

p. 177 suprimáse insértese

oblimerseno oblimersén

Proposed International Non Proprietary Names (Prop. INN): List 89

Dénominations communes internationales proposées (DCI Prop.): Liste 89
Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 89
(WHO Drug Information, Vol. 17, No. 3, 2003)

p. 186 suprimáse insértese

aprinocarseno aprinocarsén

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WHO Drug Information, Vol. 21, No. 2, 2007 Proposed INN: List 97

Proposed International Non Proprietary Names (Prop. INN): List 90

Dénominations communes internationales proposées (DCI Prop.): Liste 90
Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 90
(WHO Drug Information, Vol. 18, No. 1, 2004)

p. 49 certolizumabum pegolum
certolizumab pegol replace the description by the following
certolizumab pégol remplacer la description par la suivante
certolizumab pegol sustitúyase la descripción por la siguiente

immunoglobulin, anti-(human tumor necrosis factor α) Fab' fragment (human

mouse monoclonal CDP870 heavy chain, disulfide bonded with human mouse
monoclonal CDP870 light chain), pegylated at Cys-227 on the heavy chain

immunoglobuline, anti-(facteur α de nécrose tumorale humain) ; (disulfure entre

le fragment Fab' de la chaîne lourde et la chaîne légère de l'anticorps monoclonal
de souris CDP870 humanisé), pégylée à Cyst-227 sur la chaîne lourde

inmunoglobulina, anti-(factor α de necrosis tumoral humano) fragmento Fab'

(cadena pesada del anticuerpo monoclonal humanizado de ratón CDP870,
disulfuro con la cadena ligera del anticuerpo monoclonal humanizado de ratón
CDP870), pegilado Cis-227 de la cadena pesada

Proposed International Non Proprietary Names (Prop. INN): List 95

Dénominations communes internationales proposées (DCI Prop.): Liste 95
Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 95
(WHO Drug Information, Vol. 20, No. 2, 2006)

p. 117 aclidinii bromidum

bromuro de aclidinio sustitúyase el nombre químico por el siguiente:

bromuro de (3R)-1-(3-fenoxipropil)-3-[(hidroxibis(tiofen-2-il)acetiloxi)]-1-2-butil-
5
3-{4-[3-(dibutilamino)propil]benzoil}- 1λ -azabiciclo[2.2.2]octan-1-ilio

p. 151 delete/supprimer/suprimáse insert/insérer/insértese

ticilimumabum tremelimumabum
ticilimumab tremelimumab
ticilimumab trémélimumab
ticilimumab tremelimumab

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Proposed INN: List 97 WHO Drug Information, Vol. 21, No. 2, 2007

Proposed International Non Proprietary Names (Prop. INN): List 96

Dénominations communes internationales proposées (DCI Prop.): Liste 96
Denominaciones Comunes Internacionales Propuestas (DCI Prop.): Lista 96
(WHO Drug Information, Vol. 20, No. 4, 2006)

p. 290 managlinatum dialanetilum

managlinat dialanetil replace graphic formula by the following:
managlinat dialanétil remplacer la formule développée par la suivante:
managlinat dialanetilo sustitúyase la formúla désarollada por la siguiente:

H2N
O O CH3
N
S H
O HN
H 3C CH3
P
NH
O
H3 C H O CH3
H3C
O

* Electronic structure available on Mednet: http://mednet.who.int/

* Structure électronique disponible sur Mednet: http://mednet.who.int/
* Estructura electrónica disponible en Mednet: http://mednet.who.int/

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WHO Drug Information, Vol. 21, No. 2, 2007 Proposed INN: List 97

ANNEX 1

PROCEDURE FOR THE SELECTION OF RECOMMENDED INTERNATIONAL

NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES1

The following procedure shall be followed by the World Health Organization (hereinafter also referred to as “WHO”)
in the selection of recommended international nonproprietary names for pharmaceutical substances, in accordance with
resolution WHA3.11 of the World Health Assembly, and in the substitution of such names.

Article 1 - Proposals for recommended international nonproprietary names and proposals for substitution of such names
shall be submitted to WHO on the form provided therefore. The consideration of such proposals shall be subject to the
payment of an administrative fee designed only to cover the corresponding costs of the Secretariat of WHO (“the
Secretariat”). The amount of this fee shall be determined by the Secretariat and may, from time to time, be adjusted.

Article 2 - Such proposals shall be submitted by the Secretariat to the members of the Expert Advisory Panel on the
International Pharmacopoeia and Pharmaceutical Preparations designated for this purpose, such designated members
hereinafter referred to as “the INN Expert Group”, for consideration in accordance with the “General principles for guidance
2
in devising International Nonproprietary Names for Pharmaceutical Substances”, annexed to this procedure . The name
used by the person discovering or first developing and marketing a pharmaceutical substance shall be accepted, unless
there are compelling reasons to the contrary.

Article 3 - Subsequent to the examination provided for in article 2, the Secretariat shall give notice that a proposed
international nonproprietary name is being considered.
3
a) Such notice shall be given by publication in WHO Drug Information and by letter to Member States and to national and
regional pharmacopoeia commissions or other bodies designated by Member States.

i) Notice shall also be sent to the person who submitted the proposal (“the original applicant”) and other persons
known to be concerned with a name under consideration.

b) Such notice shall:

i) set forth the name under consideration;

ii) identify the person who submitted the proposal for naming the substance, if so requested by such person;

iii) identify the substance for which a name is being considered;

iv) set forth the time within which comments and objections will be received and the person and place to whom
they should be directed;

v) state the authority under which WHO is acting and refer to these rules of procedure.

c) In forwarding the notice, the Secretariat shall request that Member States take such steps as are necessary to prevent
the acquisition of proprietary rights in the proposed name during the period it is under consideration by WHO.

Article 4 - Comments on the proposed name may be forwarded by any person to WHO within four months of the date of
publication, under article 3, of the name in WHO Drug Information.

1
See Annex 1 in WHO Technical Report Series, No. 581, 1975; proposed amendments are shown in bold-face type. The original text was adopted by the
Executive Board in resolution EB15.R7 and amended in resolution EB43.R9.
2
See Annex 2.
3
Before 1987, lists of international nonproprietary names were published in the Chronicle of the World Health Organization.

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Proposed INN: List 97 WHO Drug Information, Vol. 21, No. 2, 2007

Article 5 - A formal objection to a proposed name may be filed by any interested person within four months of the date of
publication, under article 3, of the name in WHO Drug Information.

Such objection shall:

i) identify the person objecting;

ii) state his or her interest in the name;

iii) set forth the reasons for his or her objection to the name proposed.

Article 6 - Where there is a formal objection under article 5, WHO may either reconsider the proposed name or use its good
offices to attempt to obtain withdrawal of the objection. Without prejudice to the consideration by WHO of a substitute name
or names, a name shall not be selected by WHO as a recommended international nonproprietary name while there exists a
formal objection thereto filed under article 5 which has not been withdrawn.

Article 7 - Where no objection has been filed under article 5, or all objections previously filed have been withdrawn, the
Secretariat shall give notice in accordance with subsection (a) of article 3 that the name has been selected by WHO as a
recommended international nonproprietary name.

Article 8 - In forwarding a recommended international nonproprietary name to Member States under article 7, the Secretariat
shall:

a) request that it be recognized as the nonproprietary name for the substance; and

b) request that Member States take such steps as are necessary to prevent the acquisition of proprietary rights in the name
and to prohibit registration of the name as a trademark or trade name.

Article 9
a) In the extraordinary circumstance that a previously recommended international nonproprietary name gives rise to errors
in medication, prescription or distribution, or a demonstrable risk thereof, because of similarity with another name in
pharmaceutical and/or prescription practices, and it appears that such errors or potential errors cannot readily be resolved
through other interventions than a possible substitution of a previously recommended international nonproprietary name, or
in the event that a previously recommended international nonproprietary name differs substantially from the nonproprietary
name approved in a significant number of Member States, or in other such extraordinary circumstances that justify a
substitution of a recommended international nonproprietary name, proposals to that effect may be filed by any interested
person. Such proposals shall be submitted on the form provided therefore and shall:

i) identify the person making the proposal;

ii) state his or her interest in the proposed substitution; and

iii) set forth the reasons for the proposal; and

iv) describe, and provide documentary evidence regarding the other interventions undertaken in an effort to
resolve the situation, and the reasons why these other interventions were inadequate.

Such proposals may include a proposal for a new substitute international nonproprietary name, devised in accordance with
the General principles, which takes into account the pharmaceutical substance for which the new substitute international
nonproprietary name is being proposed.

The Secretariat shall forward a copy of the proposal, for consideration in accordance with the procedure described in
subsection (b) below, to the INN Expert Group and the original applicant or its successor (if different from the person
bringing the proposal for substitution and provided that the original applicant or its successor is known or can be found
through diligent effort, including contacts with industry associations).

In addition, the Secretariat shall request comments on the proposal from:

i) Member States and national and regional pharmacopoeia commissions or other bodies designated by Member
States (by including a notice to that effect in the letter referred to in article 3(a), and

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WHO Drug Information, Vol. 21, No. 2, 2007 Proposed INN: List 97

ii) any other persons known to be concerned by the proposed substitution.

The request for comments shall:

i) state the recommended international nonproprietary name that is being proposed for substitution (and the
proposed substitute name, if provided);

ii) identify the person who submitted the proposal for substitution (if so requested by such person);

iii) identify the substance to which the proposed substitution relates and reasons put forward for substitution;

iv) set forth the time within which comments will be received and the person and place to whom they should be
directed; and

v) state the authority under which WHO is acting and refer to these rules of procedure.

Comments on the proposed substitution may be forwarded by any person to WHO within four months of the date of the
request for comments.

b) After the time period for comments referred to above has elapsed, the Secretariat shall forward any comments received
to the INN Expert Group, the original applicant or its successor and the person bringing the proposal for substitution. If, after
consideration of the proposal for substitution and the comments received, the INN Expert Group, the person bringing the
proposal for substitution and the original applicant or its successor all agree that there is a need to substitute the previously
recommended international nonproprietary name, the Secretariat shall submit the proposal for substitution to the INN Expert
Group for further processing.
Notwithstanding the foregoing, the original applicant or its successor shall not be entitled to withhold agreement to a
proposal for substitution in the event the original applicant or its successor has no demonstrable continuing interest in the
recommended international nonproprietary name proposed for substitution.

In the event that a proposal for substitution shall be submitted to the INN Expert Group for further processing, the
INN Expert Group will select a new international nonproprietary name in accordance with the General principles referred to
in article 2 and the procedure set forth in articles 3 to 8 inclusive. The notices to be given by the Secretariat under article 3
and article 7, respectively, including to the original applicant or its successor (if not the same as the person proposing the
substitution, and provided that the original applicant or its successor is known or can be found through diligent effort,
including contacts with industry associations), shall in such event indicate that the new name is a substitute for a previously
recommended international nonproprietary name and that Member States may wish to make transitional arrangements in
order to accommodate existing products that use the previously recommended international nonproprietary name on their
label in accordance with national legislation.

If, after consideration of the proposal for substitution and the comments received in accordance with the
procedure described above, the INN Expert Group, the original applicant or its successor and the person bringing the
proposal for substitution do not agree that there are compelling reasons for substitution of a previously recommended
international nonproprietary name, this name shall be retained (provided always that the original applicant or its successor
shall not be entitled to withhold agreement to a proposal for substitution in the event that the original applicant or its
successor has no demonstrable continuing interest in the recommended international nonproprietary name proposed to be
substituted). In such an event, the Secretariat shall advise the person having proposed the substitution, as well as the
original applicant or its successor (if not the same as the person proposing the substitution, and provided that the original
applicant or its successor is known or can be found through diligent effort, including contacts with industry associations),
Member States, national and regional pharmacopoeia commissions, other bodies designated by Member States, and any
other persons known to be concerned by the proposed substitution that, despite a proposal for substitution, it has been
decided to retain the previously recommended international nonproprietary name (with a description of the reason(s) why
the proposal for substitution was not considered sufficiently compelling).

Article 10 - A working process, intended to serve as a guide for the INN Expert Group in the implementation of this
procedure, is attached hereto as an appendix.

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ANNEX 2

GENERAL PRINCIPLES FOR GUIDANCE IN DEVISING INTERNATIONAL

NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES1
1. International Nonproprietary Names (INN) should be distinctive in sound and spelling. They should not be inconveniently
long and should not be liable to confusion with names in common use.

2. The INN for a substance belonging to a group of pharmacologically related substances should, where appropriate, show
this relationship. Names that are likely to convey to a patient an anatomical, physiological, pathological or therapeutic
suggestion should be avoided.

These primary principles are to be implemented by using the following secondary principles:

3. In devising the INN of the first substance in a new pharmacological group, consideration should be given to the possibility
of devising suitable INN for related substances, belonging to the new group.

4. In devising INN for acids, one-word names are preferred; their salts should be named without modifying the acid name,
e.g. “oxacillin” and “oxacillin sodium”, “ibufenac” and “ibufenac sodium”.

5. INN for substances which are used as salts should in general apply to the active base or the active acid. Names for
different salts or esters of the same active substance should differ only in respect of the name of the inactive acid or the
inactive base.
For quaternary ammonium substances, the cation and anion should be named appropriately as separate components of a
quaternary substance and not in the amine-salt style.

6. The use of an isolated letter or number should be avoided; hyphenated construction is also undesirable.

7. To facilitate the translation and pronunciation of INN, “f” should be used instead of “ph”, “t” instead of “th”, “e” instead of
“ae” or “oe”, and “i” instead of “y”; the use of the letters “h” and “k” should be avoided.

8. Provided that the names suggested are in accordance with these principles, names proposed by the person discovering
or first developing and marketing a pharmaceutical preparation, or names already officially in use in any country, should
receive preferential consideration.

9. Group relationship in INN (see General principle 2) should if possible be shown by using a common stem. The following
list contains examples of stems for groups of substances, particularly for new groups. There are many other stems in active
2
use. Where a stem is shown without any hyphens it may be used anywhere in the name.

Latin English

-acum -ac anti-inflammatory agents, ibufenac derivatives

-adolum -adol } analgesics
-adol- -adol-}
-astum -ast anti-asthmatic, anti-allergic substances not acting primarily as
antihistaminics
-astinum -astine antihistaminics
-azepamum -azepam diazepam derivatives
bol bol steroids, anabolic
-cain- -cain- class I antiarrhythmics, procainamide and lidocaine derivatives
-cainum -caine local anaesthetics
1
In its Twentieth report (WHO Technical Report Series, No. 581, 1975), the WHO Expert committee on Nonpropriety Names for Pharmaceutical Substances
reviewed the general principles for devising, and the procedures for selecting, INN in the light of developments in pharmaceutical compounds in recent years. The
most significant change has been the extension to the naming of synthetic chemical substances of the practice previously used for substances originating in or
derived from natural products. This practice involves the use of a characteristic “stem” indicative of a common property of the members of a group. The reason for,
and the implications of, the change are fully discussed.
The guiding principles were updated during the 13th consultation on nonproprietary names for pharmaceutical substances (Geneva, 27-29 April 1983) (PHARM
S/NOM 928 13 May 1983, revised 18 August 1983).

2
A more extensive listing of stems is contained in the working document WHO/PSM/QSM/2006.3 which is regularly updated and can be requested from the INN
Programme, WHO, Geneva.

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WHO Drug Information, Vol. 21, No. 2, 2007 Proposed INN: List 97

cef- cef- antibiotics, cefalosporanic acid derivatives

-cillinum -cillin antibiotics, 6-aminopenicillanic acid derivatives
-conazolum -conazole systemic antifungal agents, miconazole derivatives
cort cort corticosteroids, except prednisolone derivatives
-coxibum -coxib selective cyclo-oxygenase inhibitors
-entanum -entan endothelin receptor antagonists
gab gab gabamimetic agents
gado- gado- diagnostic agents, gadolinium derivatives
-gatranum -gatran thrombin inhibitors, antithrombotic agents
gest gest steroids, progestogens
gli gli antihyperglycaemics
io- io- iodine-containing contrast media
-metacinum -metacin anti-inflammatory, indometacin derivatives
-mycinum -mycin antibiotics, produced by Streptomyces strains
-nidazolum -nidazole antiprotozoal substances, metronidazole derivatives
-ololum -olol β-adrenoreceptor antagonists
-oxacinum -oxacin antibacterial agents, nalidixic acid derivatives
-platinum -platin antineoplastic agents, platinum derivatives
-poetinum -poetin erythropoietin type blood factors
-pril(at)um -pril(at) angiotensin-converting enzyme inhibitors
-profenum -profen anti-inflammatory substances, ibuprofen derivatives
prost prost prostaglandins
-relinum -relin pituitary hormone release-stimulating peptides
-sartanum -sartan angiotensin II receptor antagonists, antihypertensive (non-peptidic)
-vaptanum -vaptan vasopressin receptor antagonists
vin- vin- } vinca-type alkaloids
-vin- -vin-}

ANNEXE 1

PROCEDURE A SUIVRE EN VUE DU CHOIX DE DENOMINATIONS COMMUNES

INTERNATIONALES RECOMMANDEES POUR LES SUBSTANCES
PHARMACEUTIQUES1

L’Organisation mondiale de la Santé (également désignée ci-après sous l’appellation « OMS ») observe la procédure
exposée ci-dessous pour l’attribution de dénominations communes internationales recommandées pour les substances
pharmaceutiques, conformément à la résolution WHA3.11 de l’Assemblée mondiale de la Santé, et pour le remplacement
de telles dénominations.

Article 1 - Les propositions de dénominations communes internationales recommandées et les propositions de

remplacement de telles dénominations sont soumises à l’OMS sur la formule prévue à cet effet. L’examen de telles
propositions est soumis au paiement d’une taxe administrative destinée uniquement à couvrir les coûts correspondants
assumés par le Secrétariat de l’OMS (« le Secrétariat »). Le montant de cette taxe est déterminé par le Secrétariat et peut
être modifié de temps à autre.

Article 2 - Ces propositions sont soumises par le Secrétariat aux experts désignés à cette fin parmi les personnalités
inscrites au Tableau d’experts de la Pharmacopée internationale et des Préparations pharmaceutiques, ci-après désignés
sous l’appellation « le Groupe d’experts des DCI » ; elles sont examinées par les experts conformément aux « Directives
générales pour la formation de dénominations communes internationales pour les substances pharmaceutiques »
2
reproduites ci-après . La dénomination acceptée est la dénomination employée par la personne qui découvre ou qui, la
première, fabrique et lance sur le marché une substance pharmaceutique, à moins que des raisons majeures n’obligent à
s’écarter de cette règle.

1
Voir annexe 1 dans OMS, Série de Rapports techniques, N° 581, 1975 ; les amendements proposés sont indiqués en caractères gras. Le texte original a
été adopté par le Conseil exécutif dans sa résolution EB15.R7 et amendé dans sa résolution EB43.R9.
2
Voir annexe 2.

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Proposed INN: List 97 WHO Drug Information, Vol. 21, No. 2, 2007

Article 3 - Après l’examen prévu à l’article 2, le Secrétariat notifie qu’un projet de dénomination commune internationale est
à l’étude.
1
a) Cette notification est faite par une insertion dans WHO Drug Information et par l’envoi d’une lettre aux Etats Membres et
aux commissions nationales et régionales de pharmacopée ou autres organismes désignés par les Etats Membres.

i) Notification est également faite à la personne qui a soumis la proposition (« le demandeur initial ») et à d’autres
personnes portant à la dénomination mise à l’étude un intérêt notoire.

b) Cette notification contient les indications suivantes :

i) dénomination mise à l’étude;

ii) nom de l’auteur de la proposition tendant à attribuer une dénomination à la substance, si cette personne le
demande ;

iii) définition de la substance dont la dénomination est mise à l’étude ;

iv) délai pendant lequel seront reçues les observations et les objections à l’égard de cette dénomination ; nom et
adresse de la personne habilitée à recevoir ces observations et objections ;

v) mention des pouvoirs en vertu desquels agit l’OMS et référence au présent règlement.

c) En envoyant cette notification, le Secrétariat demande aux Etats Membres de prendre les mesures nécessaires pour
prévenir l’acquisition de droits de propriété sur la dénomination proposée pendant la période au cours de laquelle cette
dénomination est mise à l’étude par l’OMS.

Article 4 - Des observations sur la dénomination proposée peuvent être adressées à l’OMS par toute personne, dans les
quatre mois qui suivent la date de publication de la dénomination dans WHO Drug Information (voir l’article 3).

Article 5 - Toute personne intéressée peut formuler une objection formelle contre la dénomination proposée dans les quatre
mois qui suivent la date de publication de la dénomination dans WHO Drug Information (voir l’article 3).

Cette objection doit s’accompagner des indications suivantes :

i) nom de l’auteur de l’objection ;

ii) intérêt qu’il ou elle porte à la dénomination en cause ;

iii) raisons motivant l’objection contre la dénomination proposée.

Article 6 - Lorsqu’une objection formelle est formulée en vertu de l’article 5, l’OMS peut soit soumettre la dénomination
proposée à un nouvel examen, soit intervenir pour tenter d’obtenir le retrait de l’objection. Sans préjudice de l’examen par
l’OMS d’une ou de plusieurs appellations de remplacement, l’OMS n’adopte pas d’appellation comme dénomination
commune internationale recommandée tant qu’une objection formelle présentée conformément à l’article 5 n’est pas levée.

Article 7 - Lorsqu’il n’est formulé aucune objection en vertu de l’article 5, ou que toutes les objections présentées ont été
levées, le Secrétariat fait une notification conformément aux dispositions du paragraphe a) de l’article 3, en indiquant que la
dénomination a été choisie par l’OMS en tant que dénomination commune internationale recommandée.

Article 8 - En communiquant aux Etats Membres, conformément à l’article 7, une dénomination commune internationale
recommandée, le Secrétariat :

a) demande que cette dénomination soit reconnue comme dénomination commune de la substance considérée ; et

b) demande aux Etats Membres de prendre les mesures nécessaires pour prévenir l’acquisition de droits de propriété sur
cette dénomination et interdire le dépôt de cette dénomination comme marque ou appellation commerciale.

1
Avant 1987, les listes de dénominations communes internationales étaient publiées dans la Chronique de l’Organisation mondiale de la Santé.

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Article 9 -
a) Dans le cas exceptionnel où une dénomination commune internationale déjà recommandée donne lieu à des erreurs de
médication, de prescription ou de distribution ou en comporte un risque démontrable, en raison d’une similitude avec une
autre appellation dans la pratique pharmaceutique et/ou de prescription, et où il apparaît que ces erreurs ou ces risques
d’erreur ne peuvent être facilement évités par d’autres interventions que le remplacement éventuel d’une dénomination
commune internationale déjà recommandée, ou dans le cas où une dénomination commune internationale déjà
recommandée diffère sensiblement de la dénomination commune approuvée dans un nombre important d’Etats Membres,
ou dans d’autres circonstances exceptionnelles qui justifient le remplacement d’une dénomination commune internationale
recommandée, toute personne intéressée peut formuler une proposition dans ce sens. Cette proposition est présentée sur
la formule prévue à cet effet et doit s’accompagner des indications suivantes :

i) nom de l’auteur de la proposition ;

ii) intérêt qu’il ou elle porte au remplacement proposé ;

iii) raisons motivant la proposition ; et

iv) description, faits à l’appui, des autres interventions entreprises pour tenter de régler le problème et exposé des
raisons pour lesquelles ces interventions ont échoué.

Les propositions peuvent comprendre une proposition de nouvelle dénomination commune internationale de remplacement,
établie conformément aux Directives générales, compte tenu de la substance pharmaceutique pour laquelle la nouvelle
dénomination commune internationale de remplacement est proposée.

Le Secrétariat transmet une copie de la proposition pour examen, conformément à la procédure exposée plus loin au
paragraphe b), au Groupe d’experts des DCI et au demandeur initial ou à son successeur (s’il s’agit d’une personne
différente de celle qui a formulé la proposition de remplacement et pour autant que le demandeur initial ou son successeur
soit connu ou puisse être retrouvé moyennant des efforts diligents, notamment des contacts avec les associations
industrielles).

De plus, le Secrétariat demande aux entités et personnes ci-après de formuler des observations sur la proposition :

i) les Etats Membres et les commissions nationales et régionales de pharmacopée ou d’autres organismes
désignés par les Etats Membres (en insérant une note à cet effet dans la lettre mentionnée à l’article 3.a), et

ii) toutes autres personnes portant au remplacement proposé un intérêt notoire.

La demande d’observations contient les indications suivantes :

i) dénomination commune internationale recommandée pour laquelle un remplacement est proposé (et la
dénomination de remplacement proposée, si elle est fournie) ;

ii) nom de l’auteur de la proposition de remplacement (si cette personne le demande) ;

iii) définition de la substance faisant l’objet du remplacement proposé et raisons avancées pour le remplacement ;

iv) délai pendant lequel seront reçus les commentaires et nom et adresse de la personne habilitée à recevoir ces
commentaires ; et

v) mention des pouvoirs en vertu desquels agit l’OMS et référence au présent règlement.

Des observations sur la proposition de remplacement peuvent être communiquées par toute personne à l’OMS dans les
quatre mois qui suivent la date de la demande d’observations.

b) Une fois échu le délai prévu ci-dessus pour la communication d’observations, le Secrétariat transmet les observations
reçues au Groupe d’experts des DCI, au demandeur initial ou à son successeur et à l’auteur de la proposition de
remplacement. Si, après avoir examiné la proposition de remplacement et les observations reçues, le Groupe d’experts des
DCI, l’auteur de la proposition de remplacement et le demandeur initial ou son successeur reconnaissent tous qu’il est
nécessaire de remplacer la dénomination commune internationale déjà recommandée, le Secrétariat soumet la proposition
de remplacement au Groupe d’experts des DCI pour qu’il y donne suite.

Nonobstant ce qui précède, le demandeur initial ou son successeur n’est pas habilité à refuser son accord à une

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proposition de remplacement au cas où il ne peut être démontré qu’il porte un intérêt durable à la dénomination commune
internationale recommandée qu’il est proposé de remplacer.

Dans le cas où une proposition de remplacement est soumise au Groupe d’experts des DCI pour qu’il y donne
suite, le Groupe choisit une nouvelle dénomination commune internationale conformément aux Directives générales
mentionnées à l’article 2 et selon la procédure décrite dans les articles 3 à 8 inclus. La notification faite par le Secrétariat en
vertu de l’article 3 et de l’article 7, respectivement, y compris au demandeur initial ou à son successeur (si ce n’est pas la
même personne que celle qui a proposé le remplacement et pour autant que le demandeur initial ou son successeur soit
connu ou puisse être retrouvé moyennant des efforts diligents, notamment des contacts avec les associations industrielles),
doit dans un tel cas indiquer que la nouvelle dénomination remplace une dénomination commune internationale déjà
recommandée et que les Etats Membres peuvent souhaiter prendre des mesures transitoires pour les produits existants qui
utilisent la dénomination commune internationale déjà recommandée sur leur étiquette conformément à la législation
nationale.

Si, après examen de la proposition de remplacement et des observations communiquées conformément à la

procédure exposée plus haut, le Groupe d’experts des DCI, le demandeur initial ou son successeur et l’auteur de la
proposition de remplacement ne s’accordent pas sur le fait qu’il y a des raisons impératives de remplacer une
dénomination commune internationale déjà recommandée, cette dernière est conservée (étant entendu toujours que le
demandeur initial ou son successeur n’est pas habilité à refuser son accord à une proposition de remplacement au cas où il
ne peut être démontré qu’il porte un intérêt durable à la dénomination commune internationale recommandée qu’il est
proposé de remplacer). Dans un tel cas, le Secrétariat informe l’auteur de la proposition de remplacement, ainsi que le
demandeur initial ou son successeur (s’il s’agit d’une personne différente de celle qui a formulé la proposition de
remplacement et pour autant que le demandeur initial ou son successeur soit connu ou puisse être retrouvé moyennant des
efforts diligents, notamment des contacts avec les associations industrielles), les Etats Membres, les commissions
nationales et régionales de pharmacopée, les autres organismes désignés par les Etats Membres et toutes autres
personnes portant un intérêt notoire au remplacement proposé que, malgré une proposition de remplacement, il a été
décidé de conserver la dénomination commune internationale déjà recommandée (avec une brève description de la ou des
raisons pour lesquelles la proposition de remplacement n’a pas été jugée suffisamment impérative).

Article 10 - Une méthode de travail, destinée à servir de guide pour le Groupe d’experts des DCI en vue de la mise en
œuvre de cette procédure, est jointe en appendice au présent texte.

ANNEXE 2

DIRECTIVES GENERALES POUR LA FORMATION DE DENOMINATIONS

COMMUNES INTERNATIONALES APPLICABLES AUX SUBSTANCES
PHARMACEUTIQUES1
1. Les dénominations communes internationales (DCI) devront se distinguer les unes des autres par leur consonance et
leur orthographe. Elles ne devront pas être d’une longueur excessive, ni prêter à confusion avec des appellations déjà
couramment employées.

2. La DCI de chaque substance devra, si possible, indiquer sa parenté pharmacologique. Les dénominations susceptibles
d’évoquer pour les malades des considérations anatomiques, physiologiques, pathologiques ou thérapeutiques devront être
évitées dans la mesure du possible.

Outre ces deux principes fondamentaux, on respectera les principes secondaires suivants :

3. Lorsqu’on formera la DCI de la première substance d’un nouveau groupe pharmacologique, on tiendra compte de la
possibilité de former ultérieurement d’autres DCI appropriées pour les substances apparentées du même groupe.

1
Dans son vingtième rapport (OMS, Série de Rapports techniques, N° 581, 1975), le Comité OMS d’experts des Dénominations communes pour les Substances
pharmaceutiques a examiné les directives générales pour la formation des dénominations communes internationales et la procédure à suivre en vue de leur choix,
compte tenu de l’évolution du secteur pharmaceutique au cours des dernières années. La modification la plus importante a été l’extension aux substances de
synthèse de la pratique normalement suivie pour désigner les substances tirées ou dérivées de produits naturels. Cette pratique consiste à employer des syllabes
communes ou groupes de syllabes communes (segments-clés) qui sont caractéristiques et indiquent une propriété commune aux membres du groupe des
substances pour lequel ces segments-clés ont été retenus. Les raisons et les conséquences de cette modification ont fait l’objet de discussions approfondies.
Les directives ont été mises à jour lors de la treizième consultation sur les dénominations communes pour les substances pharmaceutiques (Genève, 27-29 avril
1983) (PHARM S/NOM 928, 13 mai 1983, révision en date du 18 août 1983).

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4. Pour former des DCI des acides, on utilisera de préférence un seul mot. Leurs sels devront être désignés par un terme
qui ne modifie pas le nom de l’acide d’origine : par exemple «oxacilline» et «oxacilline sodique», «ibufénac» et «ibufénac
sodique».

5. Les DCI pour les substances utilisées sous forme de sels devront en général s’appliquer à la base active (ou à l’acide
actif). Les dénominations pour différents sels ou esters d’une même substance active ne différeront que par le nom de
l’acide inactif (ou de la base inactive).
En ce qui concerne les substances à base d’ammonium quaternaire, la dénomination s’appliquera de façon appropriée au
cation et à l’anion en tant qu’éléments distincts d’une substance quaternaire. On évitera de choisir une désignation
évoquant un sel aminé.

6. On évitera d’ajouter une lettre ou un chiffre isolé ; en outre, on renoncera de préférence au trait d’union.

7. Pour simplifier la traduction et la prononciation des DCI, la lettre « f » sera utilisée à la place de « ph », « t » à la place de
« th », « e » à la place de « ae » ou « oe », et « i » à la place de « y » ; l’usage des lettres « h » et « k » sera aussi évité.

8. On retiendra de préférence, pour autant qu’elles respectent les principes énoncés ici, les dénominations proposées par
les personnes qui ont découvert ou qui, les premières, ont fabriqué et lancé sur le marché les préparations
pharmaceutiques considérées, ou les dénominations déjà officiellement adoptées par un pays.

9. La parenté entre substances d’un même groupe (voir Directive générale 2) sera si possible indiquée dans les DCI par
l’emploi de segments-clés communs. La liste ci-après contient des exemples de segments-clés pour des groupes de
1
substances, surtout pour des groupes récents. Il y a beaucoup d’autres segments-clés en utilisation active. Les segments-
clés indiqués sans trait d’union pourront être insérés n’importe où dans une dénomination.

Latin Français

-acum -ac substances anti-inflammatoires du groupe de l’ibufénac

-adolum -adol } analgésiques
-adol- -adol- }
-astum -ast antiasthmatiques, antiallergiques n’agissant pas principalement en tant
qu’antihistaminiques
-astinum -astine antihistaminiques
-azepamum -azépam substances du groupe du diazépam
bol bol stéroïdes anabolisants
-cain- -caïn- antiarythmiques de classe I, dérivés du procaïnamide et de la lidocaïne
-cainum -caïne anesthésiques locaux
cef- céf- antibiotiques, dérivés de l’acide céphalosporanique
-cillinum -cilline antibiotiques, dérivés de l’acide 6-aminopénicillanique
-conazolum -conazole agents antifongiques systémiques du groupe du miconazole
cort cort corticostéroïdes, autres que les dérivés de la prednisolone
-coxibum -coxib inhibiteurs sélectifs de la cyclo-oxygénase
-entanum -entan antagonistes du récepteur de l’endothéline
gab gab gabamimétiques
gado- gado- agents diagnostiques, dérivés du gadolinium
-gatranum -gatran antithrombines, antithrombotiques
gest gest stéroïdes progestogènes
gli gli antihyperglycémiants
io- io- produits de contraste iodés
-metacinum -métacine substances anti-inflammatoires du groupe de l’indométacine
-mycinum -mycine antibiotiques produits par des souches de Streptomyces
-nidazolum -nidazole substances antiprotozoaires du groupe du métronidazole
-ololum -olol antagonistes des récepteurs β-adrénergiques
-oxacinum -oxacine substances antibactériennes du groupe de l’acide nalidixique
-platinum -platine antinéoplasiques, dérivés du platine
-poetinum -poétine facteurs sanguins de type érythropoïétine
-pril(at)um -pril(ate) inhibiteurs de l’enzyme de conversion de l’angiotensine
-profenum -profène substances anti-inflammatoires du groupe de l’ibuprofène
prost prost prostaglandines
1
Une liste plus complète de segments-clés est contenue dans le document de travail WHO/PSM/QSM/2006.3 qui est régulièrement mis à jour et qui peut être
demandé auprès du programme des DCI, OMS, Genève.

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-relinum -réline peptides stimulant la libération d’hormones hypophysaires

-sartanum -sartan antagonistes d’un récepteur de l’angiotensine II, antihypertenseurs (non
peptidiques)
-vaptanum -vaptan antagonistes du récepteur de la vasopressine
vin- vin- } alcaloïdes du type vinca
-vin- -vin- }

ANEXO 1

PROCEDIMIENTO DE SELECCIÓN DE DENOMINACIONES COMUNES

INTERNACIONALES RECOMENDADAS PARA SUSTANCIAS FARMACÉUTICAS1
La Organización Mundial de la Salud (OMS) seguirá el procedimiento que se expone a continuación tanto para seleccionar
denominaciones comunes internacionales recomendadas para las sustancias farmacéuticas, de conformidad con lo
dispuesto en la resolución WHA3.11, como para sustituir esas denominaciones.

Artículo 1 - Las propuestas de denominaciones comunes internacionales recomendadas y las propuestas de sustitución de
esas denominaciones se presentarán a la OMS en los formularios que se proporcionen a estos efectos. El estudio de estas
propuestas estará sujeto al pago de una tasa destinada a sufragar los costos de administración que ello suponga para la
Secretaría de la OMS («la Secretaría»). La Secretaría establecerá la cuantía de esa tasa y podrá ajustarla periódicamente.

Artículo 2 - Estas propuestas serán sometidas por la Secretaría a los miembros del Cuadro de Expertos en Farmacopea
Internacional y Preparaciones Farmacéuticas encargados de su estudio, en adelante designados como «el Grupo de
Expertos en DCI», para que las examinen de conformidad con los «Principios generales de orientación para formar
2
denominaciones comunes internacionales para sustancias farmacéuticas», anexos a este procedimiento. A menos que
haya poderosas razones en contra, la denominación aceptada será la empleada por la persona que haya descubierto o
fabricado y comercializado por primera vez esa sustancia farmacéutica.

Artículo 3 - Tras el examen al que se refiere el artículo 2, la Secretaría notificará que está en estudio un proyecto de
denominación internacional.
3
a) Esa notificación se hará mediante una publicación en Información Farmacéutica OMS y el envío de una carta a los
Estados Miembros y a las comisiones nacionales y regionales de las farmacopeas u otros organismos designados por los
Estados Miembros.

i) La notificación será enviada también a la persona que haya presentado la propuesta («el solicitante inicial») y a
otras personas que tengan un interés especial en una denominación objeto de estudio.

b) En esa notificación se incluirán los siguientes datos:

i) la denominación sometida a estudio;

ii) la identidad de la persona que ha presentado la propuesta de denominación de la

sustancia, si lo pide esa persona;

iii) la identidad de la sustancia cuya denominación está en estudio;

iv) el plazo fijado para recibir observaciones y objeciones, así como el nombre y la dirección de la persona a
quien deban dirigirse; y

v) los poderes conferidos para el caso a la OMS y una referencia al presente procedimiento.

1
Véase el anexo 1 en OMS, Serie de Informes Técnicos, Nº 581, 1975; las modificaciones propuestas se indican en negrita. El texto vigente fue adoptado por el
Consejo Ejecutivo en su resolución EB15.R7 y modificado en la resolución EB43.R9.
2
Véase el anexo 2.
3
Hasta 1987 las listas de DCI se publicaban en la Crónica de la Organización Mundial de la Salud.

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c) Al enviar esa notificación, la Secretaría solicitará de los Estados Miembros la adopción de todas las medidas necesarias
para impedir la adquisición de derechos de patente sobre la denominación propuesta, durante el periodo en que la OMS la
tenga en estudio.

Artículo 4 - Toda persona puede formular a la OMS observaciones sobre la denominación propuesta dentro de los cuatro
meses siguientes a su publicación en Información Farmacéutica OMS, conforme a lo dispuesto en el artículo 3.

Artículo 5 - Toda persona interesada puede presentar una objeción formal a una denominación propuesta dentro de los
cuatro meses siguientes a su publicación en Información Farmacéutica OMS, conforme a lo dispuesto en el artículo 3.
Esa objeción deberá acompañarse de los siguientes datos:

i) la identidad de la persona que formula la objeción;

ii) las causas que motivan su interés por la denominación; y

iii) las causas que motivan su objeción a la denominación propuesta.

Artículo 6 - Cuando se haya presentado una objeción formal en la forma prevista en el artículo 5, la OMS podrá
reconsiderar el nombre propuesto o utilizar sus buenos oficios para intentar lograr que se retire la objeción. La OMS no
seleccionará como denominación común internacional una denominación a la que se haya hecho una objeción formal,
presentada según lo previsto en el artículo 5, que no haya sido retirada, todo ello sin perjuicio de que la Organización
examine otra denominación o denominaciones sustitutivas.

Artículo 7 - Cuando no se haya formulado ninguna objeción en la forma prevista en el artículo 5, o cuando todas las
objeciones presentadas hayan sido retiradas, la Secretaría notificará, conforme a lo dispuesto en el párrafo a) del artículo 3,
que la denominación ha sido seleccionada por la OMS como denominación común internacional recomendada.

Artículo 8 - Al comunicar a los Estados Miembros una denominación común internacional, conforme a lo previsto en el
artículo 7, la Secretaría:

a) solicitará que esta denominación sea reconocida como denominación común para la sustancia de que se trate; y

b) solicitará a los Estados Miembros que adopten todas las medidas necesarias para impedir la adquisición de derechos de
patente sobre la denominación, y prohíban que sea registrada como marca de fábrica o como nombre comercial.

Artículo 9
a) En el caso excepcional de que, debido a su semejanza con otra denominación utilizada en las prácticas farmacéuticas
y/o de prescripción, una denominación común internacional recomendada anteriormente ocasione errores de medicación,
prescripción o distribución, o suponga un riesgo manifiesto de que esto ocurra, y parezca que tales errores o potenciales
errores no sean fácilmente subsanables con otras medidas que no sean la posible sustitución de esa denominación común
internacional recomendada anteriormente; en el caso de que una denominación común internacional recomendada
anteriormente difiera considerablemente de la denominación común aprobada en un número importante de Estados
Miembros, o en otras circunstancias excepcionales que justifiquen el cambio de una denominación común internacional
recomendada, cualquier persona interesada puede presentar propuestas en este sentido. Esas propuestas se presentarán
en los formularios que se proporcionen a estos efectos e incluirán los siguientes datos:

i) la identidad de la persona que presenta la propuesta;

ii) las causas que motivan su interés en la sustitución propuesta;

iii) las causas que motivan la propuesta; y

iv) una descripción, acompañada de pruebas documentales, de las otras medidas que se hayan adoptado con el
fin de resolver la situación y de los motivos por los cuales dichas medidas no han sido suficientes.

Entre esas propuestas podrá figurar una relativa a una nueva denominación común internacional sustitutiva,
formulada con arreglo a los Principios generales y que tenga en cuenta la sustancia farmacéutica para la que se proponga
la nueva denominación común internacional sustitutiva.

La Secretaría enviará al Grupo de Expertos en DCI y al solicitante inicial o a su sucesor (en el caso de que sea
una persona diferente de la que ha presentado la propuesta de sustitución y siempre que el solicitante inicial o su sucesor
sean conocidos o puedan ser encontrados mediante esfuerzos diligentes, como el contacto con las asociaciones

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industriales) una copia de la propuesta, para que sea examinada de conformidad con el procedimiento descrito en el
párrafo b) infra.

Además, la Secretaría solicitará observaciones sobre la propuesta:

i) a los Estados Miembros y a las comisiones nacionales y regionales de las farmacopeas u otros organismos
designados por los Estados Miembros (ello se hará incluyendo una notificación a tal efecto en la carta a la que se
refiere el párrafo a) del artículo 3), y

ii) a cualquier persona que tenga un interés especial en la sustitución propuesta.

Al solicitar que se formulen estas observaciones se facilitarán los siguientes datos:

i) la denominación común internacional recomendada que se propone sustituir (y la denominación sustitutiva

propuesta, si se ha facilitado);

ii) la identidad de la persona que ha presentado la propuesta de sustitución (si lo pide esa persona);

iii) la identidad de la sustancia a la que se refiere la sustitución propuesta y las razones para presentar la
propuesta de sustitución;

iv) el plazo fijado para recibir observaciones, así como el nombre y la dirección de la persona a quien deban
dirigirse; y

v) los poderes conferidos para el caso a la OMS y una referencia al presente procedimiento.

Toda persona puede formular a la OMS observaciones sobre la sustitución propuesta dentro de los cuatro meses
siguientes a la fecha en que se realizó la solicitud de observaciones.

b) Una vez agotado el mencionado plazo para la formulación de observaciones, la Secretaría enviará todos los comentarios
recibidos al Grupo de Expertos en DCI, al solicitante inicial o a su sucesor, y a la persona que haya presentado la
propuesta de sustitución. Si después de examinar la propuesta de sustitución y las observaciones recibidas, el Grupo de
Expertos en DCI, la persona que haya presentado la propuesta de sustitución y el solicitante inicial, o su sucesor, están de
acuerdo en la necesidad de sustituir la denominación común internacional recomendada anteriormente, la Secretaría
remitirá la propuesta de sustitución al Grupo de Expertos en DCI para que la tramite.
No obstante lo anterior, el solicitante inicial o su sucesor no tendrán derecho a impedir el acuerdo sobre una propuesta de
sustitución en el caso de que hayan dejado de tener un interés demostrable en la denominación común internacional cuya
sustitución se propone.

En caso de que la propuesta de sustitución sea presentada al Grupo de Expertos en DCI para que la tramite, este
grupo seleccionará una nueva denominación común internacional de conformidad con los Principios generales a los que se
refiere el artículo 2 y al procedimiento establecido en los artículos 3 a 8 inclusive. En ese caso, en las notificaciones que la
Secretaría ha de enviar con arreglo a los artículos 3 y 7, respectivamente, incluida la notificación al solicitante inicial o a su
sucesor (en el caso de que no sea la misma persona que propuso la sustitución y siempre que el solicitante inicial o su
sucesor sean conocidos o puedan ser encontrados mediante esfuerzos diligentes, como el contacto con las asociaciones
industriales), se indicará que la nueva denominación sustituye a una denominación común internacional recomendada
anteriormente y que los Estados Miembros podrán, si lo estiman oportuno, adoptar disposiciones transitorias aplicables a
los productos existentes en cuya etiqueta se utilice, con arreglo a la legislación nacional, la denominación común
internacional recomendada anteriormente que se haya sustituido.

En caso de que, después de haber estudiado la propuesta de sustitución y los comentarios recibidos de conformidad
con el procedimiento descrito anteriormente, el Grupo de Expertos en DCI, el solicitante inicial o su sucesor y la persona
que haya presentado la propuesta de sustitución no lleguen a un acuerdo sobre la existencia de razones poderosas para
sustituir una denominación común internacional recomendada anteriormente, esta denominación se mantendrá (siempre en
el entendimiento de que el solicitante inicial o su sucesor no tendrán derecho a impedir el acuerdo sobre una propuesta de
sustitución en el caso de que hayan dejado de tener un interés demostrable en la denominación común internacional cuya
sustitución se propone). En ese caso, la Secretaría comunicará a la persona que haya propuesto la sustitución, así como
al solicitante inicial o a su sucesor (en el caso de que no sea la misma persona que propuso la sustitución y siempre que el
solicitante inicial o su sucesor sean conocidos o puedan ser encontrados mediante esfuerzos diligentes, como el contacto
con las asociaciones industriales), a los Estados Miembros, a las comisiones nacionales y regionales de las farmacopeas o

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a otros organismos designados por los Estados Miembros y a cualquier otra persona que tenga interés en la sustitución
propuesta, que, pese a la presentación de una propuesta de sustitución, se ha decidido mantener la denominación común
internacional recomendada anteriormente (con una descripción de la o las razones por las que se ha considerado que la
propuesta de sustitución no estaba respaldada por razones suficientemente poderosas).

Artículo 10 - A fin de proporcionar orientación al Grupo de Expertos en DCI para la aplicación del presente procedimiento,
se incluye como apéndice un texto relativo al método de trabajo.

ANEXO 2

PRINCIPIOS GENERALES DE ORIENTACIÓN PARA FORMAR DENOMINACIONES

COMUNES INTERNACIONALES PARA SUSTANCIAS FARMACÉUTICAS1
1. Las denominaciones comunes internacionales (DCI) deberán diferenciarse tanto fonética como ortográficamente. No
deberán ser incómodamente largas, ni dar lugar a confusión con denominaciones de uso común.

2. La DCI de una sustancia que pertenezca a un grupo de sustancias farmacológicamente emparentadas deberá mostrar
apropiadamente este parentesco. Deberán evitarse las denominaciones que puedan tener connotaciones anatómicas,
fisiológicas, patológicas o terapéuticas para el paciente.

Estos principios primarios se pondrán en práctica utilizando los siguientes principios secundarios:

3. Al idear la DCI de la primera sustancia de un nuevo grupo farmacológico, deberá tenerse en cuenta la posibilidad de
poder formar DCI convenientes para las sustancias emparentadas que se agreguen al nuevo grupo.

4. Al idear DCI para ácidos, se preferirán las de una sola palabra; sus sales deberán denominarse sin modificar el nombre
del ácido: p. ej. «oxacilina» y «oxacilina sódica», «ibufenaco» y «ibufenaco sódico».

5. Las DCI para las sustancias que se usan en forma de sal deberán en general aplicarse a la base activa o al ácido activo.
Las denominaciones para diferentes sales o esteres de la misma sustancia activa solamente deberán diferir en el nombre
del ácido o de la base inactivos.
En los compuestos de amonio cuaternario, el catión y el anión deberán denominarse adecuadamente por separado, como
componentes independientes de una sustancia cuaternaria y no como sales de una amina.

6. Deberá evitarse el empleo de letras o números aislados; también es indeseable el empleo de guiones.

7. Para facilitar la traducción y la pronunciación, se emplearán de preferencia las letras «f» en lugar de «ph», «t» en lugar
de «th», «e» en lugar de «ae» u «oe», e «i» en lugar de «y»; se deberá evitar el empleo de las letras «h» y «k».

8. Siempre que las denominaciones propuestas estén de acuerdo con estos principios, recibirán una consideración
preferente las denominaciones propuestas por la persona que haya descubierto las sustancias, o que fabrique y
comercialice por primera vez una sustancia farmacéutica, así como las denominaciones ya adoptadas oficialmente en
cualquier país.

9. El parentesco entre sustancias del mismo grupo se pondrá de manifiesto en las DCI (véase el Principio 2) utilizando una
partícula común. En la lista que figura a continuación se indican ejemplos de partículas para grupos de sustancias, en
2
particular para grupos nuevos. Existen muchas otras partículas que se usan habitualmente. Cuando una partícula aparece
sin guión alguno, puede utilizarse en cualquier lugar de la palabra.
1
En su 20º informe (OMS, Serie de Informes Técnicos, Nº 581, 1975), el Comité de Expertos de la OMS en Denominaciones Comunes para las Sustancias
Farmacéuticas revisó los Principios generales para formar denominaciones comunes internacionales (DCI), y su procedimiento de selección, a la luz de las
novedades registradas en los últimos años en materia de compuestos farmacéuticos. El cambio más importante había consistido en hacer extensivo a la
denominación de sustancias químicas sintéticas el método utilizado hasta entonces para las sustancias originadas en productos naturales o derivadas de éstos.
Dicho método conlleva la utilización de una «partícula» característica que indica una propiedad común a los miembros de un grupo. En el citado informe se
examinan en detalle las razones y consecuencias de este cambio.
Los Principios generales de orientación se actualizaron durante la 13ª consulta sobre denominaciones comunes para sustancias farmacéuticas (Ginebra, 27 a 29 de
abril de 1983) (PHARM S/NOM 928, 13 de mayo de 1983, revisado el 18 de agosto de 1983).

2
En el documento de trabajo WHO/PSM/QSM/2006.3, que se actualiza periódicamente y puede solicitarse al Programa sobre Denominaciones Comunes
Internacionales, OMS, Ginebra, figura una lista más amplia de partículas.

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Latin Español

-acum -aco antiinflamatorios derivados del ibufenaco

-adolum -adol ) analgésicos
-adol- -adol- )
-astum -ast antiasmáticos, sustancias antialérgicas cuya acción principal no es la antihistamínica
-astinum -astina antihistamínicos
-azepamum -azepam derivados del diazepam
bol bol esteroides anabolizantes
-cain- -caína- antiarrítmicos de clase I, derivados de procainamida y lidocaína
-cainum -caína- anestésicos locales
cef- cef- antibióticos, derivados del ácido cefalosporánico
-cillinum - cilina antibióticos derivados del ácido 6-aminopenicilánico
-conazolum -conazol antifúngicos sistémicos derivados del miconazol
cort cort corticosteroides, excepto derivados de prednisolona
-coxibum -coxib inhibidores selectivos de ciclooxigenasa
-entanum -entán antagonistas del receptor de endotelina
gab gab gabamiméticos
gado- gado- agentes para diagnóstico derivados de gadolinio
-gartranum -gatrán inhibidores de la trombina antitrombóticos
gest gest esteroides progestágenos
gli gli hipoglucemiantes, antihiperglucémicos
io- io- medios de contraste iodados
-metacinum -metacina antiinflamatorios derivados de indometacina
-mycinum -micina antibióticos producidos por cepas de Streptomyces
-nidazolum -nidazol antiprotozoarios derivados de metronidazol
-ololum -olol antagonistas de receptores β-adrenérgicos
-oxacinum -oxacino antibacterianos derivados del ácido nalidíxico
-platinum -platino antineoplásicos derivados del platino
-poetinum -poetina factores sanguíneos similares a la eritropoyetina
-pril(at)um -pril(at) inhibidores de la enzima conversora de la angiotensina
-profenum -profeno antiinflamatorios derivados del ibuprofeno
prost prost prostaglandinas
-relinum -relina péptidos estimulantes de la liberación de hormonas hipofisarias
-sartanum -sartán antihipertensivos (no peptídicos) antagonistas del receptorde angiotensina II
-vaptanum -vaptán antagonistas del receptor de vasopresina
vin- vin- ) alcaloides de la vinca
-vin- -vin- )

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