Explanatory note on the withdrawal of the note for guidance on harmonisation of requirements for influenza vaccines - Scientific guideline
This document explains the withdrawal of the note for guidance on the harmonisation of requirements for influenza vaccines and its annex - cell culture inactivated influenza vaccines.
Keywords: Yearly strain update, strain change, seasonal vaccine, clinical trial, core summary of product characteristics (SmPC), effectiveness studies
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Explanatory note on the withdrawal of the Note for guidance on harmonisation of requirements for influenza Vaccines and of the core SmPC/PL for inactivated seasonal influenza vaccines (PDF/90.86 KB)
Adopted
First published: 07/02/2014
Last updated: 07/02/2014
EMA/CHMP/VWP/40560/2014 -
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Draft explanatory note on the withdrawal of the note for guidance on harmonisation of requirements for influenza Vaccines (CPMP/BWP/214/96) and of the core SmPC/PL for inactivated seasonal influenza vaccines (CMDh/128/2003/Rev5 and CMDh/129/2008/Rev3) (PDF/100.48 KB)
Draft: consultation closed
First published: 01/08/2013
Last updated: 01/08/2013
Consultation dates: 01/08/2013 to 31/10/2013
EMA/CHMP/VWP/232674/2013
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Note for guidance on harmonisation of requirements for influenza vaccines (PDF/109.15 KB)
Adopted
First published: 12/03/1997
Last updated: 12/03/1997
Legal effective date: 30/04/1997
CPMP/BWP/214/96 -
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Cell culture inactivated influenza vaccines - Annex to note for guidance on harmonisation of requirements for influenza vaccines CPMP/BWP/214/96 (PDF/177.45 KB)
Adopted
First published: 17/01/2002
Last updated: 17/01/2002
Legal effective date: 31/08/2002
CPMP/BWP/2490/00/Adopted -
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Concept paper on the development of a committee for proprietary medicinal products (CPMP) points to consider on on cell-derived influenza vaccines (PDF/27.08 KB)
First published: 29/07/1999
Last updated: 29/07/1999
CPMP/BWP/1764/99