This is a summary of the European public assessment report (EPAR) for Mavenclad. 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 Mavenclad.
For practical information about using Mavenclad, patients should read the package leaflet or contact their doctor or pharmacist.
Mavenclad : EPAR - Summary for the public (PDF/77.66 KB)
First published: 08/09/2017
Last updated: 08/09/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Merck Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
Gustav Mahlerplein 102
24/02/2021 Mavenclad - EMEA/H/C/004230 - IB/0019/G
- 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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Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.