Not a single document but a collection of regulatory documents describing the evaluation of all medicines granted or refused marketing authorization by the European Medicines Agency. Documents include a lay summary, labelling, package leaflet, summary of product characteristics, a public assessment report for the initial authorization and subsequent major changes, and an overview of procedural steps taken before and after authorization. Some information is published in all official languages of the EU while other documents are in English only, and some are only available online.
Also called EPAR.
Example: Olazax (Olanzapine) EPAR (source)
« Back to Glossary Index