18 results
Keyword priorix Remove keyword
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Referral: Priorix
measles, mumps and rubella vaccine (live), Article 30 referrals
Status: European Commission final decision, opinion/position date: 15/03/2012, EC decision date: 25/05/2012, Last updated: 19/06/2012Priorix … Agency completed a review of Priorix. The Agency's Committee for … prescribing information for Priorix in the European Union (EU … -
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Referral: Monovalent and multivalent measles, mumps, rubella and / or varicella vaccines
monovalent and multivalent measles, mumps, rubella and varicella vaccines (live), associated names: Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R. Vax, Rouvax, Trivivac, Varilrix, Varivax, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2012, EC decision date: 27/06/2013, Last updated: 12/03/2014names including Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R … names including Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 March 2012
CHMP, Last updated: 16/03/2012Novartis group of companies Priorix and associated names live … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012
CHMP, Last updated: 14/12/2012ProQuad, Zostavax, Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R … -
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Human medicine European public assessment report (EPAR): Bexsero (updated)
outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant Neisseria meningitidis group B fHbp fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B NHBA fusion protein, Meningitis, Meningococcal
Date of authorisation: 13/01/2013, Revision: 32, Authorised, Last updated: 23/05/2023 -
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Human medicine European public assessment report (EPAR): Ambirix (updated)
hepatitis A virus (inactivated), hepatitis B surface antigen, Hepatitis B; Hepatitis A; Immunization
Date of authorisation: 30/08/2002, Revision: 17, Authorised, Last updated: 24/05/2023 -
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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: 35, Authorised, Last updated: 25/05/2022 -
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Human medicine European public assessment report (EPAR): Synflorix (updated)
Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F, Pneumococcal Infections; Immunization
Date of authorisation: 29/03/2009, Revision: 36, Authorised, Last updated: 24/05/2023 -
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Human medicine European public assessment report (EPAR): Prevenar 13
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: 43, Authorised, Last updated: 15/02/2023 -
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Human medicine European public assessment report (EPAR): Quintanrix
Diphtheria toxoid, tetanus toxoid, inactivated Bordetella pertussis, hepatitis B surface antigen (rDNA), Haemophilus influenzae type b polysaccharide, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Diphtheria
Date of authorisation: 17/02/2005, Revision: 2, Withdrawn, Last updated: 10/09/2008 -
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Referral: Varilrix
live attenuated varicella virus (OKA strain), Article 30 referrals
Status: European Commission final decision, opinion/position date: 25/02/2021, EC decision date: 21/04/2021, Last updated: 09/06/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Nimenrix, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W polysaccharide conjugated to tetanus toxoid, N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000429-PIP01-08-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 08/05/2015, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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News: European Medicines Agency phasing out follow-up measures
Last updated: 01/08/2012 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 June 2011
European Medicines Agency, London, UK, from 20/06/2011 to 23/06/2011, Last updated: 11/06/2010 -
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CHMP: meeting archive 2010-2012
Last updated: 17/12/2013 -
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Management Board meeting: 16 March 2017
European Medicines Agency, London, UK, 16/03/2017, Last updated: 03/04/2017 -
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EudraVigilance
Last updated: 25/03/2020