22/12/2013

Medicine Name Product Number Active Substance Common name Atc code Azilect EMEA/H/C/000574 rasagiline rasagiline N04BD02 Actos EMEA/H/C/000285 pioglitazone pioglitazone A10BG03 Actraphane EMEA/H/C/000427 insulin human insulin human A10AD01 Acomplia EMEA/H/C/000666 rimonabant rimonabant A08AX01 Aldurazyme EMEA/H/C/000477 laronidase laronidase A16AB05 Aptivus EMEA/H/C/000631 tipranavir tipranavir J05AE09 Avonex EMEA/H/C/000102 interferon beta-1a interferon beta-1a L03AB07 Ammonaps EMEA/H/C/000219 sodium phenylbutyrate sodium phenylbutyrate A16AX03 Adcirca (previously Tadalafil EMEA/H/C/001021 Lilly) tadalafil tadalafil G04BE08 Alli (previously Orlistat EMEA/H/C/000854 GSK) orlistat orlistat A08AB01 Axura EMEA/H/C/000378 memantine hydrochloride memantine hydrochloride N06DX01 Adenuric EMEA/H/C/000777 febuxostat febuxostat M04AA03 Alimta EMEA/H/C/000564 pemetrexed pemetrexed L01BA04 Ambirix EMEA/H/C/000426 hepatitis-A virus (inactivated) hepatitis-A / hepatitis-B virus (inactivated) surface J07BC20 antigen / hepatitis-B surface anti Avastin EMEA/H/C/000582 bevacizumab bevacizumab L01XC07 Arixtra EMEA/H/C/000403 fondaparinux sodium fondaparinux sodium B01AX05 Altargo EMEA/H/C/000757 retapamulin retapamulin D06AX13 Abilify Maintena EMEA/H/C/002755 aripiprazole aripiprazole N05AX12 Agenerase EMEA/H/C/000264 amprenavir amprenavir J05AE05 Azopt EMEA/H/C/000267 brinzolamide brinzolamide S01EC04 Allex EMEA/H/C/000312 desloratadine desloratadine R06AX27 Alisade EMEA/H/C/001019 fluticasone furoate fluticasone furoate R01AD12 Angiox EMEA/H/C/000562 bivalirudin bivalirudin B01AE06 Apidra EMEA/H/C/000557 insulin glulisine insulin glulisine A10AB06 Aerinaze EMEA/H/C/000772 desloratadine / pseudophedrine desloratadine sulphate / pseudophedrine R01BA52 sulphate Abilify EMEA/H/C/000471 aripiprazole aripiprazole N05AX12 Ablavar (previously Vasovist) EMEA/H/C/000601 gadofosveset trisodium gadofosveset trisodium V08CA Arava EMEA/H/C/000235 leflunomide leflunomide L04AA13 ATryn EMEA/H/C/000587 antithrombin alfa antithrombin alfa B01AB02 Adjupanrix (previously EMEA/H/C/001206 Pandemic influenza vaccine split influenza (H5N1) (split virus, virion, inactivated, split inactivated, influenza containing virus, adjuvanted) inactivated, J07BB02 antigen: GlaxoSmithKline A/VietNam/1194/2004 containing antigen: Biologica A/ ( Arepanrix EMEA/H/C/001201 split influenza virus, inactivated, split influenza containing virus, inactivated, J07BB02 antigen* : containing A/California/7/2009 antigen* : (H Amyvid EMEA/H/C/002422 florbetapir (18F) florbetapir (18F) V09AX05 Aprovel EMEA/H/C/000141 irbesartan irbesartan C09CA04 Arzerra EMEA/H/C/001131 ofatumumab ofatumumab L01XC10 Advagraf EMEA/H/C/000712 tacrolimus tacrolimus L04AD02 Actrapid EMEA/H/C/000424 human insulin human insulin A10AB01 Actelsar HCT EMEA/H/C/002676 telmisartan / hydrochlorothiazide telmisartan / hydrochlorothiazide C09DA07 Acrescent EMEA/H/C/002424 memantine hydrochloride memantine / donepezil hydrochloride hydrochloride N06D / donepezil hydrochloride Ameluz EMEA/H/C/002204 5-aminolevulinic acid hydrochloride 5-aminolevulinic acid L01XD04 hydrochloride Aerius EMEA/H/C/000313 desloratadine desloratadine R06AX27 Alpheon EMEA/H/C/000585 recombinant human interferon recombinant alfa-2a human interferon L03AB04 alfa-2a

Ariclaim Abraxane Avaglim Aranesp Aubagio Atriance Afinitor Aclasta Avamys Adrovance Aldara Atosiban SUN Azarga Avandia Avandamet Adasuve Abseamed Advate Adcetris Azomyr Aflunov Atripla Aloxi

EMEA/H/C/000552 EMEA/H/C/000778 EMEA/H/C/000675 EMEA/H/C/000332 EMEA/H/C/002514 EMEA/H/C/000752 EMEA/H/C/001038 EMEA/H/C/000595 EMEA/H/C/000770 EMEA/H/C/000759 EMEA/H/C/000179 EMEA/H/C/002329 EMEA/H/C/000960 EMEA/H/C/000268 EMEA/H/C/000522 EMEA/H/C/002400 EMEA/H/C/000727 EMEA/H/C/000520 EMEA/H/C/002455 EMEA/H/C/000310 EMEA/H/C/002094 EMEA/H/C/000797 EMEA/H/C/000563

duloxetine duloxetine N06AX21 paclitaxel paclitaxel L01CD01 rosiglitazone / glimepiride rosiglitazone / glimepiride A10BD04 darbepoetin alfa darbepoetin alfa B03XA02 teriflunomide teriflunomide L04AA31 nelarabine nelarabine L01BB07 everolimus everolimus L01XE10 zoledronic acid zoledronic acid M05BA08 fluticasone furoate fluticasone furoate R01AD12 alendronate sodium trihydrate alendronate / colecalciferol sodium trihydrate M05BB03/ colecalciferol imiquimod imiquimod D06BB10 atosiban atosiban G02CX01 brinzolamide / timololbrinzolamide / timololS01ED51 rosiglitazone rosiglitazone A10BG02 rosiglitazone / metformin rosiglitazone hydrochloride, / metformin A10BD03 hydrochloride, loxapine loxapine N05AH01 epoetin alfa epoetin alfa B03XA01 octocog alfa octocog alfa B02BD02 brentuximab vedotin brentuximab vedotin L01XC12 desloratadine desloratadine R06AX27 influenza virus surface influenza antigensvirus (haemagglutinin surface J07BB02 antigens and neuraminidase) (haemagglutinin of and strai ne efavirenz / emtricitabine efavirenz / tenofovir / emtricitabine disoproxil J05AR06 fumarate / tenofovir disoproxil fumarate palonosetron hydrochloride palonosetron hydrochloride A04AA05

7 Westferry Circus. Canary Wharf. London. E14 4HB Tel +44 (0)20 7418 8400. Fax +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu

An Agency of the European Union

Marketing Authorisation Status Holder Revision Authorisation number date Teva Pharma GmbH Authorised 12 21/02/2005 Takeda Pharma A/S Authorised 20 13/10/2000 Novo Nordisk A/S Authorised 11 07/10/2002 sanofi-aventis Withdrawn 8 19/06/2006 Genzyme Europe B.V.Authorised 12 10/06/2003 Boehringer IngelheimAuthorised International GmbH 27 25/10/2005 Biogen Idec Ltd. Authorised 17 13/03/1997 Swedish Orphan Biovitrum Authorised International AB 12 08/12/1999 Eli Lilly Nederland B.V. Authorised 6 01/10/2008 Glaxo Group Ltd. Authorised 10 23/07/2007 Merz PharmaceuticalsAuthorised GmbH 18 17/05/2002 Menarini International Authorised Operations Luxembourg S.A.10 (MIOL) 21/04/2008 Eli Lilly Nederland B.V. Authorised 17 20/09/2004 GlaxoSmithKline Biologicals Authorised S.A. 9 30/08/2002 Roche Registration Ltd. Authorised 34 12/01/2005 Glaxo Group Ltd. Authorised 22 21/03/2002 Glaxo Group Ltd. Authorised 11 24/05/2007 Otsuka Pharmaceutical Authorised Europe Ltd 0 15/11/2013 Glaxo Group Ltd. Withdrawn 18 20/10/2000 Alcon Laboratories (UK) Authorised Ltd. 19 09/03/2000 Schering-Plough Europe Withdrawn 0 15/01/2001 Glaxo Group Ltd. Withdrawn 4 06/10/2008 The Medicines Company Authorised UK Ltd 16 20/09/2004 sanofi-aventis Deutschland Authorised GmbH 18 27/09/2004 Merck Sharp & Dohme Authorised Ltd. 11 30/07/2007 Otsuka Pharmaceutical Authorised Europe Ltd. 25 04/06/2004 TMC Pharma ServicesWithdrawn Ltd. 10 03/10/2005 Sanofi-Aventis Deutschland Authorised GmbH 26 02/09/1999 GTC Biotherapeutics UK Authorised Limited 10 28/07/2006 GlaxoSmithKline Biologicals Authorised S.A. 3 10/10/2009 GlaxoSmithKline Biologicals Withdrawn S.A. 1 23/03/2010 Eli Lilly Nederland B.V. Authorised 3 14/01/2013 Sanofi Clir SNC Authorised 30 27/08/1997 Glaxo Group Ltd Authorised 5 19/04/2010 Astellas Pharma Europe Authorised B.V. 14 23/04/2007 Novo Nordisk A/S Authorised 11 07/10/2002 Actavis Group hf Authorised 0 13/03/2013 H. Lundbeck A/S Refused 0 Biofrontera Bioscience Authorised GmbH 3 14/12/2011 Merck Sharp & Dohme Authorised Ltd. 28 15/01/2001 BioPartners GmbH Refused 0 -

Eli Lilly Nederland B.V. Authorised Celgene Europe Ltd. Authorised SmithKline Beecham Ltd Withdrawn Amgen Europe B.V. Authorised Sanofi-aventis Groupe Authorised Glaxo Group Limited Authorised Novartis Europharm Ltd. Authorised Novartis Europharm Limited Authorised Glaxo Group Limited Authorised Merck Sharp & Dohme Authorised Ltd Meda AB Authorised Sun Pharmaceutical Industries Authorised Europe B.V. Alcon Laboratories (UK) Authorised Ltd SmithKline Beecham Plc Suspended SmithKline Beecham Plc Suspended Alexza UK Ltd. Authorised Medice Arzneimittel Ptter Authorised GmbH & Co. KG Baxter AG Authorised Takeda Pharma A/S Authorised Merck Sharp & Dohme Authorised Ltd. Novartis Vaccines and Authorised Diagnostics S.r.l. Bristol-Myers Squibb Authorised and Gilead Sciences Ltd. Helsinn Birex Pharmaceuticals Authorised Ltd.

21 13 11 31 0 10 10 15 11 13 18 1 8 23 16 1 14 16 3 28 4 14 17

11/08/2004 11/01/2008 27/06/2006 08/06/2001 26/08/2013 22/08/2007 03/08/2009 15/04/2005 11/01/2008 04/01/2007 18/09/1998 31/07/2013 25/11/2008 11/07/2000 20/10/2003 20/02/2013 28/08/2007 02/03/2004 25/10/2012 15/01/2001 29/11/2010 13/12/2007 22/03/2005

rry Circus. Canary Wharf. London. E14 4HB

(0)20 7418 8400. Fax +44 (0)20 7418 8416

fo@ema.europa.eu Website www.ema.europa.eu

cy of the European Union

Indication Azilect is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa) or as adjun Pioglitazone is indicated in the treatment of type-2 diabetes mellitus:as monotherapy: in patients (particularly overweight Treatment of diabetes mellitus. As an adjunct to diet and exercise for the treatment of obese patients (BMI 30 kg/m2), or overweight patients (BMI 27 kg Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysacc Aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in Avonex is indicated for the treatment of: patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this wa Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of Adcirca is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as World Health Organiz Alli is indicated for weight loss in adults who are overweight (body mass index, BMI, 28 kg/m2) and should be taken in co Treatment of patients with moderate to severe Alzheimer's disease. Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or pre Malignant pleural mesotheliomaAlimta in combination with cisplatin is indicated for the treatment of chemotherapy-nave p Ambirix is for use in non-immune persons from one year up to and including 15 years of agefor protection against hepatitis Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with m 1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injectionPrevention of venous thromboembolic events (VTE) in adults under Short term treatment of the following superficial skin infections:impetigo.infected small lacerations, abrasions, or sutured w Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experie Azopt is indicated to decrease elevated intraocular pressure in: ocular hypertension;open-angle glaucomaas monotherapy Aerius is indicated for the relief of symptoms associated with:- allergic rhinitis (see section 5.1)- urticaria (see section 5.1) Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptom Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including pa Treatment of adults, adolescents and children,six years or older with diabetes mellitus, where treatment with insulin is req Symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion. Tablets, orodispersible tablets and oral solutionAbilify is indicated for the treatment of schizophrenia in adults and in adole This medicinal product is for diagnostic use only.Ablavaris indicated for contrast-enhanced magnetic resonance angiograph Leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirhe ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin defic Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordan Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordan This medicinal product is for diagnostic use only.Amyvid is a radiopharmaceutical indicated for positron-emission-tomograp Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus Treatment of chronic lymphocytic leukaemia (CLL) in patients who are refractory to fludarabine and alemtuzumab. Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to tr Treatment of diabetes mellitus. Treatment of essential hypertension.Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazid Treatment of Alzheimers disease Treatment of actinic keratosis of mild to moderate intensity on the face and scalp (Olsen grade 1 to 2). Aerius is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria. Adult patients with histologically proven chronic hepatitis C who are positive for hepatitis C virus (HCV) antibodies or HCV

Treatment of diabetic peripheral neuropathic pain.Ariclaim is indicated in adults. Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in patients who have failed first-line trea AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic c Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.Treatment Treatment of adult patients with relapsing-remitting multiple sclerosis (MS). Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphobl Hormone-receptor-positive advanced breast cancerAfinitor is indicated for the treatment of hormone-receptor-positive, HE Treatment of osteoporosis:in post-menopausal women;in men;at increased risk of fracture, including those with a recent lo Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency.Adrovance reduces the risk of vert Imiquimod cream is indicated for the topical treatment of:external genital and perianal warts (condylomata acuminata) in Atosiban is indicated to delay imminent pre-term birth in pregnant adult women with:regular uterine contractions of at lea Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monot Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:as monotherapy-in patients (particularly overweight AVANDAMET is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients:who are un Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar diso Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:treatment o Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).Advate does not c Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):followin Azomyr is indicated for the relief of symptoms associated with:allergic rhinitis (see section 5.1);urticaria (see section 5.1). Active immunisation against H5N1 subtype of influenza-A virus.This indication is based on immunogenicity data from healt Atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate. It is indicated for the trea Solution for injectionAloxi is indicated for:the prevention of acute nausea and vomiting associated with highly emetogenic

Condition Exceptional Approval Is Circumstance OrphanIs GenericBiosimilar no no no no no no no no no no no no no no no no no no no no no yes no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no no yes no no no no yes no no no yes no no no no no no no no no no no no no no yes no yes no no no no no no no no no no no no no no no yes no no no no no no no no no no no no no no no no no no no no yes

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