Ocrevus

RSS

ocrelizumab

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 03/10/2022

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
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
08/01/2018
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

21/09/2022 Ocrevus - EMEA/H/C/004043 - R/0033

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

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