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

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Current effective version

Adopted guideline

Reference numberCPMP/QWP/159/96 Corr.
Published01/02/2003
Effective from01/08/2003
KeywordsShelf-life, sterile products, stability, opening, reconstitution
DescriptionThis 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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