This is a summary of the European public assessment report (EPAR) for Bavencio. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Bavencio.
For practical information about using Bavencio, patients should read the package leaflet or contact their doctor or pharmacist.
Bavencio : EPAR - Summary for the public (PDF/72.29 KB)
First published: 13/10/2017
Last updated: 13/10/2017
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This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Merck Europe B.V.
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31/08/2018 Bavencio - EMEA/H/C/004338 - R/0003
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).