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Keyword Boostrix Remove keyword
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National expert: Paolo Durando, Italian Medicines Agency (updated)
- Declaration of interests - 88.4 KB | PDF
- Curriculum Vitae - 0 bytes | PDF
04/2009-11/2009 GlaxoSmithKline Boostrix-IPV/Tetravac Prevention of diphtheria … 10/2011-03/2013 Novartis Vaccine Tdap, Boostrix® - Gardasil® - Menveo® … -
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National expert: Nicolas Dauby, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 81.17 KB | PDF
- Curriculum Vitae - 32.66 KB | PDF
studying the immune response to Boostrix vaccine during pregnancy … -
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Human medicine European public assessment report (EPAR): Cervarix
human papillomavirus1 type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Immunization
Date of authorisation: 20/09/2007, Revision: 33, Authorised, Last updated: 23/06/2020 -
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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: 5, Authorised, Last updated: 28/09/2020
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Human medicine European public assessment report (EPAR): Menveo
meningococcal group A, C, W-135 and Y conjugate vaccine, Immunization, Meningitis, Meningococcal
Date of authorisation: 15/03/2010,
Date of refusal: 17/12/2009, Revision: 29, Authorised, Last updated: 26/02/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigen: Pertussis toxoid, Bordetella pertussis antigen: Filamentous Haemagglutinin, Bordetella pertussis antigen: Pertactin, Inactivated poliovirus: type 1 (Mahoney strain), Inactivated poliovirus: type 2 (MEF-1 strain), Inactivated poliovirus: type 3 (Saukett strain)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000500-PIP01-08-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection, Suspension for injection in pre-filled syringe
Decision date: 07/03/2015, Last updated: 25/03/2015, Compliance check: V, 27/05/2016type 3 (Saukett strain) (Boostrix Polio and associated names … type 3 (Saukett strain) (Boostrix Polio and associated names … type 3 (Saukett strain) (Boostrix Polio and associated names … -
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Opinion/decision on a Paediatric investigation plan (PIP): Outer membrane vesicles from Neisseria meningitidis strain NZ 98/254, recombinant N. meningitis
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-001260-PIP01-11, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder and suspension for suspension for injection
Decision date: 20/12/2012, Last updated: 11/02/2013, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Menveo, Meningococcal group A oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenA-CRM) Meningococcal group C oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenC-CRM) Meningococcal group W-135 oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenW-CRM) Meningococcal group Y oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenY-CRM)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000032-PIP01-07-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 01/04/2011, Last updated: 12/05/2011, Compliance check: V, 25/05/2011 -
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Public data from Article 57 database (updated)
Last updated: 16/02/2021 -
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Article 5(3) opinions (updated)
Last updated: 26/02/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 March 2018
European Medicines Agency, London, UK, from 19/03/2018 to 22/03/2018, Last updated: 31/05/2018 -
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Committee for Medicinal Products for Human Use (CHMP): 22-25 January 2018
European Medicines Agency, London, UK, from 22/01/2018 to 25/01/2018, Last updated: 06/01/2014 -
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News: EMA publishes 2013 annual report
Last updated: 30/04/2014 -
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Annual reports and work programmes
Last updated: 15/06/2020 -
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News: Progress in science, medicine and health
Last updated: 17/05/2016 -
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News: Annual report 2009 published: "Agency achieved very good results in one of the most challenging years in its history"
Last updated: 20/05/2010 -
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CHMP: meeting archive 2016-2018
Last updated: 26/02/2020