European Medicines Agency

Authorized Vaccines

Trade Name	Product Name / Diseases	Manufacturer	Last Label Update	First Published	Package Insert
Adjupanrix	Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)	GlaxoSmithKline Biologicals	8/6/2022	17/12/2009
Aflunov	zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)	Seqirus	3/10/2022	24/01/2011
Ambirix	Hepatitis-A (inactivated) and hepatitis-B (rDNA) (HAB) vaccine (adsorbed)	GlaxoSmithKline Biologicals	14/01/2022	24/09/2007
Bexsero	Meningitis, Meningococcal	GSK Vaccines	12/10/2022	28/01/2012
Cervarix	Immunization; Papillomavirus Infections; Uterine Cervical Dysplasia	GlaxoSmithKline Biologicals	3/11/2021	2/12/2009
Comirnaty	COVID-19 virus infection		2/2/2023	12/1/2021
Dengvaxia	Dengue	Sanofi Pasteur	26/01/2022	18/12/2018
Dukoral	Cholera; Immunization	Valneva Sweden	6/4/2022	4/5/2009
Ebilfumin	Influenza, Human	Actavis Group	8/12/2021	6/6/2014
Emtriva	HIV Infections	Gilead Sciences	31/05/2021	9/7/2009
Entecavir Accord	Hepatitis B, Chronic	Accord Healthcare	29/07/2022	26/01/2018
Entecavir Mylan	Hepatitis B	Mylan Pharmaceuticals	29/07/2022	10/10/2017
Epclusa	Hepatitis C, Chronic	Gilead Sciences	6/7/2022	28/07/2016
Ervebo	Hemorrhagic Fever, Ebola	Merck Sharp & Dohme	4/8/2022	12/12/2019
Exviera	Hepatitis C, Chronic	AbbVie	12/8/2022	12/2/2015
Fendrix	Hepatitis B; Immunization	GlaxoSmithKline Biologicals	14/01/2022	7/4/2009
Fluad Tetra	Influenza, Human	Seqirus	16/01/2023	29/05/2020
Flucelvax Tetra	Influenza, Human	Seqirus	1/8/2022	19/10/2018
Fluenz Tetra	Influenza, Human	AstraZeneca	9/2/2023	17/12/2013
Foclivia	Disease Outbreaks; Immunization; Influenza, Human	Seqirus	6/4/2022	17/12/2009
Gardasil	Condylomata Acuminata; Immunization; Papillomavirus Infections; Uterine Cervical Dysplasia	Merck Sharp & Dohme	8/11/2022	25/09/2009
Gardasil 9	Condylomata; Acuminata; Immunization; Papillomavirus Infections Uterine Cervical Dysplasia	Merck Sharp & Dohme	8/11/2022	3/7/2015
Granupas (previously Para-aminosalicylic acid Lucane)	Tuberculosis	Eurocept International	11/10/2022	12/5/2014
Harvoni	Hepatitis C, Chronic	Gilead Sciences	10/11/2022	4/12/2014
HBVaxPro	Hepatitis B; Immunization	Merck Sharp & Dohme	16/08/2022	20/02/2008
Heplisav B	Hepatitis B	Dynavax	11/1/2022	1/3/2021
Hexacima	Diphtheria; Hepatitis ; Immunization; Meningitis; Haemophilus; Poliomyelitis; Tetanus; Whooping Cough	Sanofi Pasteur	6/1/2023	12/7/2013
Hexyon	Diphtheria Hepatitis B; Immunization; Meningitis, Haemophilus; Poliomyelitis; Tetanus; Whooping Cough	Sanofi Pasteur	6/1/2023	12/7/2013
Imvanex	Smallpox	Bavarian Nordic	25/07/2022	16/08/2013
Infanrix Hexa	Diphtheria; Hepatitis B; Immunization; Meningitis, Haemophilus; Poliomyelitis; Tetanus; Whooping Cough	GlaxoSmithKline Biologicals s.a.	11/5/2022	26/11/2008
Invanz	Community-Acquired Infections; Gram-Negative Bacterial Infections; Pneumonia, Bacterial; Staphylococcal Infections; Streptococcal Infections; Surgical Wound Infection	Merck Sharp & Dohme	25/10/2022	28/10/2009
Ixiaro	Encephalitis, Japanese; Immunization	Valneva Austria	12/4/2021	6/5/2009
Jcovden (previously COVID-19 Vaccine Janssen)	COVID-19 virus infection	Janssen-Cilag	10/1/2023	11/3/2021
Lamivudine Teva	Hepatitis B, Chronic	Teva	17/11/2022	9/11/2009
Maviret	Hepatitis C, Chronic	AbbVie Deutschland	2/3/2023	17/08/2017
MenQuadfi	Meningitis, Meningococcal	Sanofi Pasteur	1/3/2023	27/11/2020
Menveo	Immunization; Meningitis, Meningococcal	GSK Vaccines	18/01/2022	4/5/2010
M-M-RVAXPRO	Immunization; Measles; Mumps; Rubella	Merck Sharp & Dohme	14/07/2022	4/8/2008
Mvabea	Hemorrhagic Fever, Ebola	Janssen-Cilag	10/1/2022	23/07/2020
Nimenrix	Meningitis, Meningococcal	Pfizer Europe	25/05/2022	24/05/2012
Nuvaxovid	COVID-19 virus infection	Novavax CZ	10/1/2023	20/12/2021
Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)	Influenza, Human	AstraZeneca	6/10/2022	2/6/2016
Pandemic Influenza Vaccine H5N1 Baxter AG	Influenza, Human; Immunization; Disease Outbreaks	Resilience Biomanufacturing	6/2/2023	17/12/2009
Pegasys	Hepatitis B, Chronic; Hepatitis C, Chronic	zr pharma	7/11/2022	16/11/2009
PreHevbri	Hepatitis B	VBI Vaccines	Not stated in the package insert	18/05/2022
Prevenar 13	Immunization; Pneumococcal Infections	Pfizer Europe	26/10/2021	8/1/2010
ProQuad	Chickenpox; Immunization; Measles; Mumps; Rubella	Merck Sharp & Dohme	22/07/2022	12/8/2009
Rebetol	Hepatitis C, Chronic	Merck Sharp and Dohme	24/11/2022	22/10/2009
Rotarix	Immunization; Rotavirus Infections	GlaxoSmithKline Biologicals	5/4/2022	5/10/2009
RotaTeq	Immunization; Rotavirus Infections	Merck Sharp & Dohme	16/08/2022	4/12/2009
Shingrix	Herpes Zoster	GlaxoSmithkline Biologicals	19/12/2022	28/03/2018
Sirturo	Tuberculosis, Multidrug-Resistant	Janssen-Cilag International	23/11/2021	14/03/2014
Sovaldi	Hepatitis C, Chronic	Gilead Sciences	22/08/2022	5/2/2014
Spikevax (previously COVID-19 Vaccine Moderna)	COVID-19 virus infection	Moderna Biotech Spain	22/12/2022	20/01/2021
Supemtek	Influenza, Human	Sanofi Pasteur	28/07/2022	25/11/2020
Synflorix	Immunization; Pneumococcal Infections	GlaxoSmithKline Biologicals	26/08/2022	8/7/2009
Tamiflu	Influenza, Human	Roche Registration	25/11/2021	1/12/2009
Tecovirimat SIGA	Poxviridae Infections; Cowpox; Monkeypox; Vaccinia; Smallpox	SIGA Technologies Netherlands	Not stated in the package insert	28/01/2022
Trumenba	Meningitis, Meningococcal	Pfizer Europe	14/11/2022	6/6/2017
Twinrix Adult	Hepatitis A; Hepatitis B; Immunization	GlaxoSmithKline Biologicals	14/01/2022	9/7/2008
Twinrix Paediatric	Hepatitis A; Hepatitis B; Immunization	GlaxoSmithKline Biologicals	14/01/2022	9/7/2008
Valneva	COVID-19 virus infection	Valneva Austria	17/02/2023	23/06/2022
Vaxchora	Cholera	Emergent Netherlands	27/09/2022	8/4/2020
Vaxelis	Diphtheria Hepatitis B Meningitis, Haemophilus Poliomyelitis Tetanus Whooping Cough	MCM Vaccine	20/02/2023	26/02/2016
Vaxneuvance	Pneumococcal Infections	Merck Sharp & Dohme	29/11/2022	17/01/2022
Vaxzevria (previously COVID-19 Vaccine AstraZeneca)	COVID-19 virus infection	AstraZeneca	20/02/2023	18/02/2021
Vemlidy	Hepatitis B	Gilead Sciences	5/9/2022	10/3/2017
VidPrevtyn Beta	COVID-19 virus infection	Sanofi Pasteur	11/11/2022	10/11/2022
Viekirax	Hepatitis C, Chronic	AbbVie Deutschland	12/8/2022	9/3/2015
ViraferonPeg	Hepatitis C, Chronic	Merck Sharp Dohme	22/01/2021	17/09/2009
Viread	HIV Infections; Hepatitis B, Chronic	Gilead Sciences	4/1/2023	3/8/2009
Vosevi	Hepatitis C, Chronic	Gilead Sciences	7/7/2022	22/09/2017
Xevudy	COVID-19 virus infection	GlaxoSmithKline Trading Services	12/1/2023	16/12/2021
Zabdeno	Hemorrhagic Fever, Ebola	Janssen-Cilag International	5/1/2022	23/07/2020
Zeffix	Hepatitis B, Chronic	GlaxoSmithKline (Ireland)	19/07/2022	2/9/2009
Zinforo	Community-Acquired Infections; Pneumonia; Skin Diseases, Infectious	Pfizer Ireland	22/07/2022	18/09/2012
Zostavax	Herpes Zoster; Immunization	Merck Sharp & Dohme	1/7/2022	14/12/2009
Zutectra	Hepatitis B; Immunization, Passive; Liver Transplantation	Biotest Pharma	31/08/2022	12/2/2010

 

Previously Authorized Vaccines

Trade Name	Product Name / Diseases	Manufacturer	Last Label Update	First Published	Package Insert
Atripla	HIV Infection	Gilead Sciences	21/01/2022	13/10/2009
Celvapan	Disease Outbreaks; Immunization; Influenza, Human	Baxter	21/12/2016	15/11/2009
Crixivan	HIV Infections	Merck Sharp & Dohme	7/7/2022	23/07/2009
Daklinza	Hepatitis C, Chronic	Bristol-Myers Squibb	22/08/2019	15/9/2014
Dutrebis	HIV Infections	Merck Sharp Dohme	27/04/2017	21/04/2015
Focetria	Disease Outbreaks; Immunization; Influenza, Human	Novartis Vaccines and Diagnostics	13/2/2015	4/12/2009
Hepsera	Hepatitis B, Chronic	Gilead Sciences	1/3/2023	9/7/2009
IDflu	Immunization; Influenza, Human	Sanofi Pasteur	28/03/2018	11/5/2009
Incivo	Hepatitis C, Chronic	Janssen-Cilag	6/10/2016	3/10/2011
Intanza	Immunization; Influenza, Human	Sanofi Pasteur	4/9/2018	28/04/2009
IntronA	Carcinoid Tumor; Hepatitis B, Chronic; Hepatitis C, Chronic; Leukemia, Hairy Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Lymphoma, Follicular; Melanoma; Multiple Myeloma	Merck Sharp & Dohme	14/12/2022	1/4/2009
Ketek	Bronchitis, Chronic; Community-Acquired Infections; Pharyngitis; Pneumonia, Bacterial; Sinusitis; Tonsillitis	Aventis Pharma	19/06/2019	16/11/2009
Olysio	Hepatitis C, Chronic	Janssen-Cilag	23/05/2018	4/6/2014
Optaflu	Immunization; Influenza, Human	Seqirus	13/02/2017	11/5/2009
Pandemrix	Disease Outbreaks; Immunization; Influenza, Human	GlaxoSmithKline Biologicals	24/09/2014	23/12/2009
PegIntron	Hepatitis C, Chronic	Merck Sharp & Dohme	3/6/2021	17/09/2009
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)	Disease Outbreaks; Immunization; Influenza, Human	Novartis Vaccines and Diagnostics	4/4/2012	24/01/2011
Prepandrix	Disease Outbreaks; Immunization; Influenza, Human	GlaxoSmithKline Biologicals	26/07/2019	21/12/2009
Prevenar	Immunization; Pneumococcal Infections	Pfizer	24/11/2017	8/10/2009
Pumarix	Disease Outbreaks; Immunization; Influenza, Human	GlaxoSmithKline Biologicals	13/05/2014	5/4/2011
Ribavirin Mylan (previously Ribavirin Three Rivers)	Hepatitis C, Chronic	Mylan	31/07/2019	2/7/2010
Ribavirin Teva	Hepatitis C, Chronic	Teva	9/7/2021	16/11/2009
Ribavirin Teva Pharma B.V.	Hepatitis C, Chronic	Teva	9/7/2021	19/10/2009
Sebivo	Hepatitis B, Chronic	Novartis Europharm	14/01/2021	12/10/2009
Silgard	Condylomata Acuminata; Immunization; Papillomavirus Infections; Uterine Cervical Dysplasia	Merck Sharp Dohme	2/4/2019	25/09/2009
Vepacel	Disease Outbreaks; Immunization; Influenza, Human	Ology Bioservices	22/01/2019	16/03/2012
Victrelis	Hepatitis C, Chronic	Merck Sharp Dohme	31/07/2018	3/8/2011
Vitekta	HIV Infections	Gilead Sciences	29/05/2017	26/11/2013
Zerit	HIV Infections	Bristol-Myers Squibb	27/03/2019	11/8/2006

 

Updated March 3, 2023