Annex I variation application(s) content for live attenuated influenza vaccines

This document explains the quality aspects of technical requirements for annual strain update. It has been superseded by the guideline on influenza vaccines - quality module.

Keywords: Human influenza, live attenuated vaccine, variation procedure, community annual strain update, fast-track, season

Current effective version

Annex I variation application(s) content for live attenuated influenza vaccines

Adopted Reference Number: EMA/CHMP/BWP/577998/2010 Summary:

This Annex contains the quality aspects of technical requirements for annual strain update. The nonclinical and clinical aspects are currently under preparation and will be published separately when completed.

Document history

Overview of comments received on 'Annex I variation application(s) content for live attenuated influenza vaccines'

Reference Number: EMA/CHMP/BWP/367594/2011

Annex I variation application(s) content for live attenuated influenza vaccines

Draft Consultation dates: 16/12/2010 to 31/03/2011 Reference Number: EMA/CHMP/BWP/577998/2010