EMA

European Medicines Agency

Trade Name	Product Name / Diseases	Manufacturer	Last Label Update	First Published
Adjupanrix	Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)	GlaxoSmithKline Biologicals	28/1/2016	17/12/2009
Aflunov	Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)	Novartis Vaccines and Diagnostics S.r.l.	14/8/2015	24/1/2011
Ambirix	Hepatitis-A (inactivated) and hepatitis-B (rDNA) (HAB) vaccine (adsorbed)	GlaxoSmithKline Biologicals	10/12/2015	24/9/2007
Aptivus	HIV Infection	Boehringer Ingelheim International	10/12/2015	17/12/2009
Atripla	HIV Infection	Gilead Sciences	17/8/2015	13/10/2009
Baraclude	Hepatitis B, Chronic	Bristol-Myers Squibb	01/12/2015	13/10/2009
Benlysta	Lupus Erythematosus; Systemic	GlaxoSmithKline Manufacturing	7/11/2014	9/8/2011
Bexsero	Meningitis; Meningococcal	GSK Vaccines	11/1/2016	28/1/2012
Cancidas (previously Caspofungin MSD)	Aspergillosis; Candidiasis	Merck Sharp & Dohme	1/6/2015	5/8/2009
Celsentri	HIV Infections	Pfizer Manufacturing	8/1/2016	11/8/2009
Celvapan	Disease Outbreaks; Immunization; Influenza, Human	Baxter	27/1/2016	15/11/2009
Cervarix	Immunization; Papillomavirus Infections; Uterine Cervical Dysplasia	GlaxoSmithKline Biologicals	2/12/2015	2/12/2009
Cholestagel	Hypercholesterolemia	Genzyme	13/2/2015	3/5/2010
Combivir	HIV Infections	Glaxo Operations	07/3/2016	28/4/2009
Crixivan	HIV Infections	Merck Sharp & Dohme	5/2/2016	23/7/2009
Cubicin	Bacteremia; Endocarditis; Bacterial; Gram-Positive Bacterial Infections; Soft Tissue Infections	Novartis Pharma	16/6/2014	9/9/2009
Daklinza	Hepatitis C, Chronic	Bristol-Myers Squibb	5/11/2015	15/9/2014
DepoCyte	Meningeal Neoplasms	Almac Pharma Services Limited	2/7/2015	8/6/2009
Dificlir	Clostridium Infections	Astellas Pharma Europe	11/8/2014	19/12/2011
Dukoral	Cholera; Immunization	Crucell	29/5/2015	4/5/2009
Dutrebis	HIV Infections	Merck Sharp & Dohme	21/04/2015	26/03/2015
Ebilfumin	Influenza, Human	Actavis	17/08/2015	06/06/2014
Edurant	HIV Infections	Janssen-Cilag	7/3/2016	12/12/2011
Efavirenz Teva	HIV Infections	Teva Pharmaceutical Works Private Limited Company	13/4/2015	27/1/2012
Emtriva	HIV Infections	Gilead Sciences	26/8/2015	9/7/2009
Exviera	Hepatitis C, Chronic	AbbVie	17/12/2015	12/2/2015
Eviplera	HIV Infections	Gilead Sciences	7/3/2016	12/12/2011
Evotaz	HIV Infections	Bristol-Myers Squibb Pharma	10/8/2015	13/7/2015
Fendrix	Hepatitis B; Immunization	GlaxoSmithKline Biologicals	10/12/2015	7/4/2009
Flebogamma DIF (previously Flebogammadif)	Bone Marrow Transplantation; Guillain-Barre Syndrome; Immunologic Deficiency Syndromes; Mucocutaneous Lymph Node Syndrome; Purpura, Thrombocytopenic, Idiopathic	Instituto Grifols	14/01/2015	18/8/2009
Fluenz Tetra	Influenza, Human	MedImmune	29/2/2016	17/12/2013
Foclivia	Disease Outbreaks; Immunization; Influenza, Human	Novartis Vaccines and Diagnostics	6/8/2014	8/3/2016
Fuzeon	HIV Infections	Roche Pharma	18/1/2016	24/10/2008
Gardasil	Condylomata Acuminata; Immunization; Papillomavirus Infections; Uterine Cervical Dysplasia	Merck Sharp and Dohme	9/3/2016	25/9/2009
Gardasil 9	Condylomata; Acuminata; Immunization; Papillomavirus Infections Uterine Cervical Dysplasia	Merck Sharp and Dohme	7/3/2016	3/7/2015
Genvoya	HIV Infections	Gilead Sciences	Not stated in the package insert	19/11/2015
Granupas (previously Para-aminosalicylic acid Lucane)	Tuberculosis	Lucane Pharma	23/7/2014	12/5/2014
Grastofil	Neutropenia	Apotex	10/2/2016	11/11/2013
Harvoni	Hepatitis C, Chronic	Gilead Sciences	23/2/2016	4/12/2014
HBVaxPro	Hepatitis B; Immunization	Merck Sharp and Dohme	15/7/2015	19/2/2008
Helicobacter Test INFAI	Breath Tests; Helicobacter Infections	INFAI, Institut fr Biomedizinische Analytik und NMR-Imaging	19/5/2015	14/7/2009
Hepsera	Hepatitis B, Chronic	Gilead Sciences	21/4/2015	9/7/2009
Hexacima	Diphtheria; Hepatitis ; Immunization; Meningitis; Haemophilus; Poliomyelitis; Tetanus; Whooping Cough	Sanofi Pasteur	15/3/2016	12/7/2013
Hexyon	Diphtheria Hepatitis B; Immunization; Meningitis, Haemophilus; Poliomyelitis; Tetanus; Whooping Cough	Sanofi Pasteur	29/1/2016	12/7/2013
Hizentra	Immunologic; Deficiency Syndromes	CSL Behring	9/1/2015	6/6/2011
HyQvia	Immunologic, Deficiency Syndromes	Baxter	1/2/2016	3/6/2013
IDflu	Immunization; Influenza, Human	Sanofi Pasteur	28/10/2015	11/5/2009
Imvanex	Smallpox	Bavarian Nordic	12/2/2016	16/8/2013
Incivo	Hepatitis C, Chronic	Janssen-Cilag	13/8/2015	3/10/2011
Infanrix Hexa	Diphtheria; Hepatitis B; Immunization; Meningitis, Haemophilus; Poliomyelitis; Tetanus; Whooping Cough	GlaxoSmithKline Biologicals s.a.	22/12/2015	26/11/2008
Intanza	Immunization; Influenza, Human	Sanofi Pasteur	28/9/2015	28/04/2009
Intelence	HIV Infections	Janssen-Cilag	7/3/2016	7/8/2009
IntronA	Carcinoid Tumor; Hepatitis B, Chronic; Hepatitis C, Chronic; Leukemia, Hairy Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Lymphoma, Follicular; Melanoma; Multiple Myeloma	SP Labo	8/1/2016	1/4/2009
Invanz	Community-Acquired Infections; Gram-Negative Bacterial Infections; Pneumonia, Bacterial; Staphylococcal Infections; Streptococcal Infections; Surgical Wound Infection	Merck Sharp & Dohme	11/03/2016	28/10/2009
Invirase	HIV Infections	Roche	24/2/2016	8/4/2009
Isentress	HIV Infections	Merck Sharp & Dohme	9/3/2015	18/09/2009
Ixiaro	Encephalitis, Japanese; Immunization	Valneva Scotland Ltd.	30/10/2015	6/5/2009
Kaletra	HIV Infections	Aesica Queenborough Ltd	15/2/2016	23/09/2009
Ketek	Bronchitis, Chronic; Community-Acquired Infections; Pharyngitis; Pneumonia, Bacterial; Sinusitis; Tonsillitis	S.C. Zentiva	25/1/2016	16/11/2009
Kiovig	Bone Marrow Transplantation; Guillain-Barre Syndrome; Immunologic Deficiency Syndromes; Mucocutaneous ; Lymph Node Syndrome; Purpura, Thrombocytopenic, Idiopathic	Baxter	5/2/2016	23/10/2007
Kivexa	HIV Infections	Glaxo Wellcome	9/3/2016	16/7/2007
Lamivudine Teva	Hepatitis B, Chronic	Teva Pharmaceutical Works	14/1/2015	9/11/2009
Lamivudine Teva Pharma B.V.	HIV Infections	Teva Pharmaceutical Works	8/2/2016	16/12/2009
Lamivudine/Zidovudine Teva	HIV Infections	Teva Pharmaceutical Works	18/12/2014	15/03/2011
LeukoScan	Osteomyelitis; Radionuclide Imaging	Immunomedics	Not stated in the package insert	13/08/2007
Lopinavir/Ritonavir Mylan	HIV Infections	Mylan SAS	9/2/2016	14/1/2016
Menveo	Immunization; Meningitis, Meningococcal	GSK Vaccines	7/10/2015	4/5/2010
M-M-RVAXPRO	Immunization; Measles; Mumps; Rubella	Merck Sharp and Dohme	11/8/2015	4/8/2008
Mycamine	Candidiasis	Astellas	4/2/2016	15/12/2009
Nevirapine Teva	HIV Infections	TEVA Pharmaceutical Works Private Limited Company	30/10/2014	14/12/2009
Nimenrix	Meningitis, Meningococcal	Pfizer	9/2/2016	24/05/2012
Nivestim	Cancer; Hematopoietic Stem Cell Transplantation; Neutropenia	Hospira Enterprises	26/8/2015	23/06/2010
Norvir	HIV Infections	AbbVie	2/3/2016	15/11/2009
NovoSeven	Factor VII Deficiency; Hemophilia A; Hemophilia B; Thrombasthenia	Novo Nordisk	2/7/2014	14/07/2009
Noxafil	Aspergillosis; Candidiasis; Coccidioidomycosis; Mycoses	SP Labo	19/8/2015	30/11/2009
Olysio	Hepatitis C, Chronic	Janssen-Cilag SpA	25/9/2015	4/6/2014
Optaflu	Immunization; Influenza, Human	Novartis Influenza Vaccines	18/3/2016	11/5/2009
Pandemic Influenza Vaccine H5N1	Disease Outbreaks; Immunization; Influenza, Human	Baxter	18/1/2016	17/12/2009
Pegasys	Hepatitis B, Chronic; Hepatitis C, Chronic	Roche Pharma	29/2/2016	16/11/2009
PegIntron	Hepatitis C, Chronic	SP Labo N.V.	22/10/2015	17/09/2009
Prepandrix	Disease Outbreaks; Immunization; Influenza, Human	GlaxoSmithKline Biologicals s.a.	29/1/2016	21/12/2009
Prevenar	Immunization; Pneumococcal Infections	John Wyeth & Brother	16/7/2015	8/10/2009
Prevenar 13	Immunization; Pneumococcal Infections	Wyeth Pharmaceuticals	21/12/2015	8/1/2010
Prezista	HIV Infections	Janssen-Cilag	27/11/2014	5/11/2009
Privigen	Bone Marrow Transplantation; Guillain-Barre Syndrome; Immunologic Deficiency Syndromes; Mucocutaneous Lymph Node Syndrome; Purpura, Thrombocytopenic, Idiopathic	CSL Behring	27/1/2016	11/9/2009
ProQuad	Chickenpox; Immunization; Measles; Mumps; Rubella	Merck Sharp and Dohme	26/1/2016	12/8/2009
Pylobactell	Breath Tests; Helicobacter Infections	J L Bragg	24/05/2012	14/08/2008
Ratiograstim	Cancer; Hematopoietic Stem Cell Transplantation; Neutropenia	Merckle Biotec	14/3/2016	26/11/2009
Rebetol	Hepatitis C, Chronic	SP S.A.	9/12/2015	22/10/2009
Revolade	Purpura, Thrombocytopenic, Idiopathic	Glaxo Operations	27/11/2015	29/04/2010
Reyataz	HIV Infections	Bristol-Myers Squibb	14/08/2014	15/12/2009
Rezolsta	HIV Infections	Janssen-Cilag	15/3/2016	12/12/2014
Ribavirin Mylan (previously Ribavirin Three Rivers)	Hepatitis C, Chronic	Penn Pharmaceutical Services Ltd	26/09/2014	2/7/2010
Ribavirin Teva	Hepatitis C, Chronic	Teva Pharmaceutical Works Private Limited Company	22/12/2014	16/11/2009
Ribavirin Teva Pharma B.V.	Hepatitis C, Chronic	Teva Pharmaceutical Works Private Limited Company	22/12/2014	19/10/2009
Rotarix	Immunization; Rotavirus Infections	GlaxoSmithKline Biologicals	29/2/2016	5/10/2009
RotaTeq	Immunization; Rotavirus Infections	Merck Sharp and Dohme	1/3/2016	3/12/2009
Scintimun	Osteomyelitis; Radionuclide Imaging	CIS bio international	11/3/2016	15/3/2010
Sebivo	Hepatitis B, Chronic	Novartis Pharma GmbH	3/12/2014	12/10/2009
Silgard	Condylomata Acuminata; Immunization; Papillomavirus Infections; Uterine Cervical Dysplasia	Merck Sharp and Dohme	18/3/2016	25/9/2009
Sirturo	Tuberculosis, Multidrug-Resistant	Janssen Pharmaceutica	14/3/2016	14/3/2014
Sovaldi	Hepatitis C, Chronic	Gilead Sciences	15/3/2016	5/2/2014
Stocrin	HIV Infections	Merck Sharp & Dohme	15/3/2016	13/1/2010
Stribild	HIV Infections	Gilead Sciences	29/2/2016	13/6/2013
Sustiva	HIV Infections	Bristol-Myers Squibb	19/5/2015	16/11/2009
Sylvant	Giant Lymph Node; Hyperplasia	Janssen Biologics	23/7/2015	19/6/2014
Synagis	Respiratory Syncytial; Virus Infections	AbbVie	3/2/2016	4/12/2009
Synflorix	Immunization; Pneumococcal Infections	GlaxoSmithKline Biologicals	27/1/2016	8/7/2009
Tamiflu	Influenza, Human	Roche Pharma	31/7/2015	1/12/2009
Telzir	HIV Infections	Aspen Bad Oldesloe	12/1/2016	15/12/2009
Tevagrastim	Cancer; Hematopoietic Stem Cell Transplantation; Neutropenia	Teva Pharma	3/1/2014	19/10/2009
Tivicay	HIV Infections	Glaxo Wellcome	15/1/2016	5/2/2014
Tobi Podhaler	Cystic Fibrosis; Respiratory Tract Infections	Novartis Pharma	21/12/2015	25/08/2011
Triumeq	HIV Infections	Glaxo Wellcome	9/11/2015	15/10/2014
Trizivir	HIV Infections	Glaxo Operations	26/10/2015	9/12/2009
Truvada	HIV Infections	Gilead Sciences	7/3/2016	11/6/2009
Twinrix Adult	Hepatitis A; Hepatitis B; Immunization	GlaxoSmithKline Biologicals	9/12/2015	9/7/2008
Twinrix Paediatric	Hepatitis A; Hepatitis B; Immunization	GlaxoSmithKline Biologicals	4/12/2015	9/7/2008
Tybost	HIV Infections	Gilead Sciences	4/6/2015	24/10/2013
Tygacil	Bacterial Infections; Skin Diseases, Bacterial; Soft Tissue Infections	Wyeth Pharmaceuticals	27/8/2015	12/8/2009
Vaxelis	Diphtheria Hepatitis B Meningitis, Haemophilus Poliomyelitis Tetanus Whooping Cough	Sanofi Pasteur	Not stated in the package insert	26/2/2016
Vepacel	Disease Outbreaks; Immunization; Influenza, Human	Baxter	19/1/2016	16/3/2012
Vfend	Aspergillosis; Candidiasis; Mycoses	Fareva Amboise	29/01/2016	27/10/2009
Victrelis	Hepatitis C, Chronic	S-P Labo	11/3/2016	3/8/2011
Viekirax	Hepatitis C, Chronic	AbbVie	30/11/2015	9/3/2015
ViraferonPeg	Hepatitis C, Chronic	SP Labo	25/9/2015	17/09/2009
Viramune	HIV Infections	Boehringer Ingelheim Pharma	12/2/2016	11/6/2009
Viread	HIV Infections; Hepatitis B, Chronic	Gilead Sciences	11/2/2015	3/8/2009
Vitekta	HIV Infections	Gilead Sciences	17/3/2016	26/11/2013
Voriconazole Accord	Aspergillosis; Candidiasis; Mycoses	Accord Healthcare	15/3/2016	7/6/2013
Zarzio	Cancer; Hematopoietic Stem Cell Transplantation; Neutropenia	Sandoz	19/8/2015	9/11/2009
Zeffix	Hepatitis B, Chronic	Aspen Bad Oldesloe	5/2/2016	2/9/2009
Zerit	HIV Infections	Bristol-Myers Squibb	11/2/2016	16/11/2009
Ziagen	HIV Infections	Aspen Bad Oldesloe	9/11/2015	11/12/2009
Zinforo	Community-Acquired Infections; Pneumonia; Skin Diseases, Infectious	AstraZeneca; Facta Farmaceutici	4/2/2016	18/09/2012
Zostavax	Herpes Zoster; Immunization	Merck Sharp and Dohme	16/2/2016	14/12/2009
Zutectra	Hepatitis B; Immunization, Passive; Liver Transplantation	Biotest Pharma	23/2/2016	12/2/2010

No Longer Authorised Vaccines

Trade Name	Product Name / Diseases	Manufacturer	Last Label Update	First Published
Focetria	Disease Outbreaks; Immunization; Influenza, Human	Novartis Vaccines and Diagnostics	13/2/2015	4/12/2009
Pandemrix	Disease Outbreaks; Immunization; Influenza, Human	GlaxoSmithKline Biologicals	24/09/2014	23/12/2009
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)	Disease Outbreaks; Immunization; Influenza, Human	Novartis Vaccines and Diagnostics	4/4/2012	24/01/2011
Pumarix	Disease Outbreaks; Immunization; Influenza, Human	GlaxoSmithKline Biologicals	13/05/2014	5/4/2011

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