Medicine data: European public assessment reports (EPAR) for human medicines

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Provided by European Medicines Agency

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Dataset information

Country of origin
Updated
2019.01.09 00:00
Created
2015.12.15
Available languages
English
Keywords
refused medicine, EPAR, human medicines, assessment reports, marketing authorisation, authorised medicine
Quality scoring
325

Dataset description

The EMA publishes an EPAR for every medicine granted a central marketing authorisation by the European Commission following an assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). EPARs are full scientific assessment reports of medicines authorised at a European Union level. You can find information including a public-friendly summary in question-and-answer format and the package leaflet. You can also find information on medicines that have been refused a marketing authorisation or that have been suspended or withdrawn after being approved. Different filter options on the website allow for browsing the data by the therapeutic area or type (orphan, generic, biosimilar etc.). Search results can be exported in Excel format. The Agency does not evaluate all medicines currently in use in Europe. If you cannot find the medicine you need through this search, please visit the website of your national health authority.
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