270 results
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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,
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, Revision: 5, Authorised, Last updated: 22/07/2021
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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: 10, Authorised, Last updated: 22/07/2021
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
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: 9, Authorised, Last updated: 21/07/2021
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Human medicine European public assessment report (EPAR): Fluad Tetra (updated)
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/(H1N1)-like virus antigen / A/(H3N2)-like virus antigen / B (victoria lineage)-like virus antigen B (yamagata lineage)-like virus antigen, Influenza, Human
Date of authorisation: 20/05/2020,, Revision: 1, Authorised, Last updated: 20/07/2021
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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: 10, Authorised, Last updated: 19/07/2021
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Human medicine European public assessment report (EPAR): M-M-RVaxPro (updated)
measles virus Enders’ Edmonston strain (live, attenuated), mumps virus Jeryl Lynn (level B) strain (live, attenuated), rubella virus Wistar RA 27/3 strain (live, attenuated), Rubella, Mumps, Immunization, Measles
Date of authorisation: 05/05/2006, Revision: 27, Authorised, Last updated: 14/07/2021 -
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Human medicine European public assessment report (EPAR): Prevenar 13 (updated)
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal Infections, Immunization
Date of authorisation: 09/12/2009, Revision: 41, Authorised, Last updated: 13/07/2021 -
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Human medicine European public assessment report (EPAR): Fluenz Tetra (updated)
reassortant influenza virus (live attenuated) of the following four strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Bolivia/559/2013, MEDI 255962)A/Hong Kong/4801/2014 (H3N2) - like strain(A/New Caledonia/71/2014, MEDI 263122)B/Brisbane/60/2008 - like strain(B/Brisbane/60/2008, MEDI 228030)B/Phuket/3073/2013 - like strain(B/Phuket/3073/2013, MEDI 254977), Influenza, Human
Date of authorisation: 04/12/2013, Revision: 20, Authorised, Last updated: 08/07/2021 -
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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: 8, Authorised, Last updated: 08/07/2021
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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: 8, Authorised, Last updated: 05/07/2021
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Human medicine European public assessment report (EPAR): Rotarix (updated)
human rotavirus, live attenuated, Immunization, Rotavirus Infections
Date of authorisation: 21/02/2006, Revision: 36, Authorised, Last updated: 28/06/2021 -
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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: 18/06/2021 -
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Human medicine European public assessment report (EPAR): RotaTeq
rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1, Immunization, Rotavirus Infections
Date of authorisation: 26/06/2006, Revision: 30, Authorised, Last updated: 04/06/2021 -
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Veterinary medicine European public assessment report (EPAR): MS-H Vaccine
Mycoplasma synoviae strain MS-H, Chicken
Date of authorisation: 14/06/2011, Revision: 6, Authorised, Last updated: 03/06/2021 -
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Human medicine European public assessment report (EPAR): Vaxchora
vibrio cholerae, strain cvd 103-hgr, live, Cholera
Date of authorisation: 01/04/2020,, Revision: 3, Authorised, Last updated: 27/05/2021
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Veterinary medicine European public assessment report (EPAR): Enteroporc Coli
Inactivated fimbrial adhesins of Escherichia coli F4ab, Inactivated fimbrial adhesins of Escherichia coli F4ac, Inactivated fimbrial adhesins of Escherichia coli F5, Inactivated fimbrial adhesins of Escherichia coli F6, Pigs
Date of authorisation: 06/01/2021, Revision: 1, Authorised, Last updated: 12/05/2021 -
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Veterinary medicine European public assessment report (EPAR): Prevexxion RN
Live recombinant Marek’s disease (MD) virus, serotype 1, strain RN1250, Chicken
Date of authorisation: 20/07/2020, Revision: 1, Authorised, Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Aflunov
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 28/11/2010, Revision: 13, Authorised, Last updated: 06/05/2021 -
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Human medicine European public assessment report (EPAR): Shingrix
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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Veterinary medicine European public assessment report (EPAR): Nobilis IB Primo QX
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
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): MenQuadfi
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
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
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): 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