Ocrevus
ocrelizumab
Table of contents
Overview
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.
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List item
Ocrevus : EPAR - Summary for the public (PDF/84.29 KB)
First published: 11/01/2018
Last updated: 25/01/2018
EMA/10371/2018 -
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List item
Ocrevus : EPAR - Risk-management-plan summary (PDF/390.56 KB)
First published: 17/01/2019
Last updated: 11/01/2021
Authorisation details
Product details | |
---|---|
Name |
Ocrevus
|
Agency product number |
EMEA/H/C/004043
|
Active substance |
ocrelizumab
|
International non-proprietary name (INN) or common name |
ocrelizumab
|
Therapeutic area (MeSH) |
Multiple Sclerosis
|
Anatomical therapeutic chemical (ATC) code |
L04AA
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Roche Registration GmbH
|
Revision |
9
|
Date of issue of marketing authorisation valid throughout the European Union |
08/01/2018
|
Contact address |
Product information
11/01/2021 Ocrevus - EMEA/H/C/004043 - PSUSA/00010662/202003
Contents
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
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.