Explanatory note on the withdrawal of the note for guidance on harmonisation of requirements for influenza vaccines
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