Human medicines European public assessment report (EPAR): Ocrevus, ocrelizumab, Date of authorisation: 08/01/2018, Revision: 26, Status: Authorised

Ocrevus RSS Authorised This medicine is authorised for use in the European Union ocrelizumab Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision 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. Expand section Collapse section What is Ocrevus and what is it used for? Ocrevus is a medicine for treating multiple sclerosis – an inflammatory disease of the nervous system that causes symptoms such as weakness, difficulty walking and problems with vision. Ocrevus is used in two types of patients: adults with relapsing forms of multiple sclerosis (RMS), where the patient has flare-ups (relapses) followed by periods with milder or no symptoms; adults with primary progressive multiple sclerosis (PPMS), where symptoms get steadily worse over time. Ocrevus contains the active substance ocrelizumab. How is Ocrevus used? Ocrevus is given as an infusion (drip) into a vein. The first two infusions are given two weeks apart and subsequent infusions are given every six months. Before each infusion, the patient is given other medicines (a corticosteroid and an antihistamine) to help to prevent potentially dangerous reactions. If reactions occur during an infusion it may be stopped or given more slowly. The patient should be monitored during the infusion and for at least an hour afterwards, and facilities to manage severe reactions should be readily available. Ocrevus can only be obtained with a prescription and treatment must only be started and supervised by a doctor experienced in treating diseases of the nerves. For further information, see the package leaflet. How does Ocrevus work? The active substance in Ocrevus, ocrelizumab, is a monoclonal antibody designed to recognise and attach to a target called CD20 on the surface of certain types of white blood cells (so called B cells). These white blood cells play a role in multiple sclerosis by attacking the sheaths around the nerves in the brain and spinal cord, causing inflammation and damage. By targeting the B cells, Ocrevus helps to reduce their activity and thereby relieves symptoms or slows down the worsening of the disease. What benefits of Ocrevus have been shown in studies? Studies have shown that Ocrevus is effective at reducing the number of relapses and it can also reduce the worsening of symptoms in some patients. In two studies of 1,656 patients with relapsing forms of multiple sclerosis (RMS), the average number of relapses in patients treated with Ocrevus was about half that in patients treated with another medicine interferon beta-1a (0.16 versus 0.29 relapses per year). A third study, in 732 patients with primary progressive multiple sclerosis (PPMS), showed that fewer patients taking Ocrevus had worsening symptoms lasting 12 weeks or more (30%) compared with those taking a placebo (34%). What are the risks associated with Ocrevus? The most important and most frequently reported side effects with Ocrevus are infusion reactions (such as itching, rash, and difficulty breathing) and infections. These occur in more than 1 in 10 people. For the full list of side effects reported with Ocrevus, see the package leaflet. Ocrevus must not be used in patients with active infections or severely weakened immune systems or in patients with cancer. For the full list of restrictions, see the package leaflet. Why is Ocrevus approved? Studies showed that Ocrevus was more effective than interferon beta-1a at reducing the number of relapses in patients with relapsing forms of multiple sclerosis. Ocrevus treatment also provided some benefit in patients with primary progressive multiple sclerosis, a condition for which treatments are urgently needed. The European Medicines Agency concluded that the benefits seen with Ocrevus outweighed its risks and recommended that it be authorised in the EU. What measures are being taken to ensure the safe and effective use of Ocrevus? Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ocrevus have been included in the summary of product characteristics and the package leaflet. Other information about Ocrevus The European Commission granted a marketing authorisation valid throughout the European Union for Ocrevus on 8 January 2018. For more information about treatment with Ocrevus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Ocrevus : EPAR - Summary for the public Reference Number: EMA/10371/2018 English (EN) (84.29 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View Other languages (22) български (BG) (109.83 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View español (ES) (83.46 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View čeština (CS) (108.17 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View dansk (DA) (82.65 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View Deutsch (DE) (84.29 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View eesti keel (ET) (83.37 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View ελληνικά (EL) (110.47 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View français (FR) (84.28 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View hrvatski (HR) (103.04 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View italiano (IT) (82.68 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View latviešu valoda (LV) (106 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View lietuvių kalba (LT) (106.91 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View magyar (HU) (104.9 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View Malti (MT) (108.62 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View Nederlands (NL) (83.22 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View polski (PL) (109.15 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View português (PT) (84.07 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View română (RO) (104.4 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View slovenčina (SK) (108.2 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View slovenščina (SL) (100.76 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View Suomi (FI) (82.68 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View svenska (SV) (82.98 KB - PDF) First published: 11/01/2018 Last updated: 25/01/2018 View Ocrevus : EPAR - Risk management plan English (EN) (7.06 MB - PDF) First published: 10/11/2023 Last updated: 16/04/2026 View Product information Ocrevus : EPAR - Product Information English (EN) (672.44 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View Other languages (24) български (BG) (1.21 MB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View español (ES) (970.43 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View čeština (CS) (934.67 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View dansk (DA) (845.71 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View Deutsch (DE) (833.4 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View eesti keel (ET) (863.17 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View ελληνικά (EL) (1.05 MB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View français (FR) (843.47 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View hrvatski (HR) (958.34 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View íslenska (IS) (792.04 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View italiano (IT) (931.16 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View latviešu valoda (LV) (1.17 MB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View lietuvių kalba (LT) (1022.14 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View magyar (HU) (1008.21 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View Malti (MT) (914.39 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View Nederlands (NL) (837.93 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View norsk (NO) (849.94 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View polski (PL) (986.14 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View português (PT) (824.62 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View română (RO) (894.16 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View slovenčina (SK) (853.99 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View slovenščina (SL) (1.09 MB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View Suomi (FI) (819.19 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View svenska (SV) (733.48 KB - PDF) First published: 11/01/2018 Last updated: 06/05/2025 View Latest procedure affecting product information: VR/0000254616 29/04/2025 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: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). Ocrevus : EPAR - All Authorised presentations English (EN) (20.15 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View Other languages (24) български (BG) (44.08 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View español (ES) (20.46 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View čeština (CS) (71.84 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View dansk (DA) (20.32 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View Deutsch (DE) (19.22 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View eesti keel (ET) (19.93 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View ελληνικά (EL) (41.85 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View français (FR) (23.02 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View hrvatski (HR) (41.05 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View íslenska (IS) (25.32 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View italiano (IT) (19.4 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View latviešu valoda (LV) (45.32 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View lietuvių kalba (LT) (38.27 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View magyar (HU) (28.13 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View Malti (MT) (42.54 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View Nederlands (NL) (19.13 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View norsk (NO) (22.97 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View polski (PL) (40.1 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View português (PT) (23.71 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View română (RO) (40.75 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View slovenčina (SK) (41.55 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View slovenščina (SL) (28.2 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View Suomi (FI) (20.04 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View svenska (SV) (25.77 KB - PDF) First published: 11/01/2018 Last updated: 24/06/2024 View Product details Name of medicine Ocrevus Active substance ocrelizumab International non-proprietary name (INN) or common name ocrelizumab Therapeutic area (MeSH) Multiple Sclerosis Anatomical therapeutic chemical (ATC) code L04AG08 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. Authorisation details EMA product number EMEA/H/C/004043 Marketing authorisation holder Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany Opinion adopted 09/11/2017 Marketing authorisation issued 08/01/2018 Revision 26 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Ocrevus : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (158.19 KB - PDF) First published: 06/05/2025 Last updated: 16/04/2026 View Ocrevus : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (232.08 KB - PDF) First published: 11/04/2018 Last updated: 25/03/2025 View Ocrevus-H-C-PSUSA-00010662-202403 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Adopted Reference Number: EMA/514030/2024 English (EN) (130.81 KB - PDF) First published: 15/01/2025 View Ocrevus-H-C-004043-X-0039 : EPAR - Assessment report - Variation Adopted Reference Number: EMA/CHMP/171408/2024 English (EN) (6.13 MB - PDF) First published: 24/06/2024 View Ocrevus-H-C-PSUSA-00010662- 202003 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMA/668602/2020 English (EN) (131.32 KB - PDF) First published: 22/01/2021 View Ocrevus-H-C-PSUSA-00010662- 201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Adopted Reference Number: EMA/601109/2019 English (EN) (67.21 KB - PDF) First published: 06/01/2020 View Ocrevus-H-C-PSUSA-00010662- 201809 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Adopted Reference Number: EMA/CHMP/285789/2019 English (EN) (68.19 KB - PDF) First published: 26/06/2019 View Initial marketing authorisation documents Ocrevus : EPAR - Public assessment report Adopted Reference Number: EMA/790835/2017 English (EN) (5 MB - PDF) First published: 11/01/2018 Last updated: 11/01/2018 View CHMP summary of positive opinion Ocrevus Adopted Reference Number: EMA/CHMP/643958/2017 English (EN) (71.29 KB - PDF) First published: 10/11/2017 Last updated: 10/11/2017 View News on Ocrevus New medicine for multiple sclerosis 10/11/2017 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017 10/11/2017 More information on Ocrevus EMEA-000310-PIP03-10-M06 - paediatric investigation plan EMEA-000310-PIP05-22 - paediatric investigation plan Safety and Effectiveness of Ocrelizumab under Real World Conditions: a Non-Interventional Post Authorization Safety Study in Patients Diagnosed with Relapsing or Primary Progressive Multiple Sclerosis (CONFIDENCE) - post-authorisation study Topics Medicines This page was last updated on 16/04/2026 Share this page