242 results
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Human medicine European public assessment report (EPAR): Shingrix (updated)
Recombinant varicella zoster virus glycoprotein E, Herpes Zoster
Date of authorisation: 21/03/2018,
, Revision: 6, Authorised, Last updated: 30/04/2021
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, 
, Revision: 6, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,, , Revision: 6, Authorised, Last updated: 28/04/2021
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Veterinary medicine European public assessment report (EPAR): Nobilis IB Primo QX (updated)
live avian infectious bronchitis virus, strain D388, Chicken
Date of authorisation: 04/09/2014, Revision: 5, Authorised, Last updated: 26/04/2021 -
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Veterinary medicine European public assessment report (EPAR): Nobilis IB 4-91 (updated)
live attenuated avian infectious bronchitis virus variant strain 4-91, Chicken
Date of authorisation: 09/06/1998, Revision: 15, Authorised, Last updated: 26/04/2021 -
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Janssen (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , Revision: 1, Authorised, Last updated: 23/04/2021
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Human medicine European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) (updated)
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human
Date of authorisation: 20/05/2016,, , Revision: 7, Authorised, Last updated: 23/04/2021
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Hawaii/70/2019 (H1N1)pdm09-like strain (A/Nebraska/14/2019, wild type); A/Hong Kong/45/2019 (H3N2)-like strain (A/Delaware/39/2019, wild type); B/Washington/02/2019-like strain (B/Darwin/7/2019, wild type); B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 7, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): MenQuadfi (updated)
Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 18/11/2020,, Revision: 1, Authorised, Last updated: 19/04/2021
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Human medicine European public assessment report (EPAR): Ixiaro (updated)
Japanese-encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells), Encephalitis, Japanese, Immunization
Date of authorisation: 31/03/2009, Revision: 17, Authorised, Last updated: 12/04/2021 -
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Veterinary medicine European public assessment report (EPAR): Syvazul BTV (updated)
Inactivated bluetongue virus, serotype 1, strain ALG2006/01 E1, Inactivated bluetongue virus, serotype 4, strain BTV-4/SPA-1/2004, Inactivated bluetongue virus, serotype 8, strain BEL2006/01, Cattle, Sheep
Date of authorisation: 09/01/2019, Revision: 2, Authorised, Last updated: 08/04/2021 -
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Human medicine European public assessment report (EPAR): Vaxchora (updated)
vibrio cholerae, strain cvd 103-hgr, live, Cholera
Date of authorisation: 01/04/2020,, Revision: 2, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,, , Revision: 1, Authorised, Last updated: 30/03/2021
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Human medicine European public assessment report (EPAR): Hexyon
filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Diphtheria toxoid, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 24, Authorised, Last updated: 25/03/2021 -
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Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N2
inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), Chicken
Date of authorisation: 01/09/2006,
, Revision: 8, Authorised, Last updated: 25/03/2021
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Human medicine European public assessment report (EPAR): Hexacima
hepatitis B surface antigen, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett), Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 23, Authorised, Last updated: 25/03/2021 -
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Veterinary medicine European public assessment report (EPAR): Innovax-ND-IBD
Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of ND virus and the VP2 protein of IBD virus, Chicken, Embryonated chicken eggs
Date of authorisation: 22/08/2017, Revision: 4, Authorised, Last updated: 24/03/2021 -
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Veterinary medicine European public assessment report (EPAR): Innovax-ILT
Cell-associated live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus, Chicken
Date of authorisation: 03/07/2015, Revision: 4, Authorised, Last updated: 24/03/2021 -
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Human medicine European public assessment report (EPAR): Nimenrix
Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 20/04/2012, Revision: 33, Authorised, Last updated: 24/03/2021 -
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Veterinary medicine European public assessment report (EPAR): Innovax-ND-ILT
Cell-associated live recombinant turkey herpesvirus (strain HVT/NDV/ILT) expressing the fusion protein of newcastle disease virus and the glycoproteins gD and gI of infectious laryngotracheitis virus, Embryonated chicken eggs, Chicken
Date of authorisation: 16/09/2020, Revision: 1, Authorised, Last updated: 24/03/2021 -
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Human medicine European public assessment report (EPAR): Trumenba
Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B, Meningitis, Meningococcal
Date of authorisation: 24/05/2017,, Revision: 9, Authorised, Last updated: 17/03/2021
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Human medicine European public assessment report (EPAR): Foclivia
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009,
, Revision: 11, Authorised, Last updated: 10/03/2021
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Human medicine European public assessment report (EPAR): Gardasil 9
human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed), Condylomata Acuminata, Papillomavirus Infections, Immunization, Uterine Cervical Dysplasia
Date of authorisation: 09/06/2015, Revision: 15, Authorised, Last updated: 08/03/2021 -
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Veterinary medicine European public assessment report (EPAR): Gumbohatch
live attenuated infectious bursal disease virus (IBDV), strain 1052, Chicken, Embryonated chicken eggs
Date of authorisation: 12/11/2019, Revision: 2, Authorised, Last updated: 05/03/2021 -
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Veterinary medicine European public assessment report (EPAR): Evalon
vaccine against coccidiosis in chickens, Chicken
Date of authorisation: 18/04/2016, Revision: 2, Authorised, Last updated: 26/02/2021