This is a summary of the European public assessment report (EPAR) for Ocrevus. 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 Ocrevus.
For practical information about using Ocrevus, patients should read the package leaflet or contact their doctor or pharmacist.
Ocrevus : EPAR - Summary for the public (PDF/84.29 KB)
First published: 11/01/2018
Last updated: 25/01/2018
Ocrevus : EPAR - Risk-mamanegement-plan summary (PDF/375.53 KB)
First published: 17/01/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Roche Registration GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
20/06/2019 Ocrevus - EMEA/H/C/004043 - PSUSA/00010662/201809
- 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 relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
Treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.