Pharmaceutical and biological aspects of combined vaccines

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Current effective version

Adopted guideline

Reference numberCPMP/BWP/477/97
Published23/07/1998
Effective from11/01/1999
KeywordsVaccines, combined vaccines, multivalent vaccines, quality data, harmonisation, adjuvant, antigen, antimicrobial agents, preservatives, stability, release testing, potency, immunogenicity
DescriptionThis document explains how to ensure that new combined vaccines and combined vaccines that are new to particular manufacturer fulfil the highest standard of the quality, safety and efficacy. It provides uniform criteria for the evaluation of combined vaccines by the competent authorities.


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