Maximum shelf-life for sterile products for human use after first opening or following reconstitution

Current effective version

PDF iconAdopted guideline

Reference number CPMP/QWP/159/96 Corr.
Published 01/02/2003
Effective from 01/08/2003
Keywords Shelf-life, sterile products, stability, opening, reconstitution
Description This document describes the information to be provided on maximum shelf-life for sterile products for human use after first opening or following reconstitution. It includes some recommendations for the user information texts (e.g. SmPC, package insert, labels). It applies to all sterile products for human use, with the exception of radiopharmaceuticals and extemporaneously prepared or modified preparations.


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