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

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.

Keywords: Shelf-life, sterile products, stability, opening, reconstitution

Current effective version

Note for guidance on maximum shelf-life for sterile products for human use after first opening or following reconstitution

AdoptedLegal effective date: 01/07/1998Reference Number: CPMP/QWP/159/96