Pharmaceutical aspects of the product information for human vaccines

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberCPMP/BWP/2758/02
Published26/11/2003
Effective from01/06/2004
KeywordsVaccine, label, summary of product characteristics, patient leaflet, braille
DescriptionThis document provides guidance on the pharmaceutical data applicable to product information for human vaccines. It covers information to be provided for the summary of product characteristics, labelling and package lefleat.


Document history

Revision 1 

In progress

Concept paperPublished: 17/06/2009

First version

Current version

Adopted guideline

In operation: 01/06/2004–present


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