Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Ocrevus 920 mg solution for injection.
| Pharmaceutical Form |
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Solution for injection. Clear to slightly opalescent, and colourless to pale brown solution, with a pH of approximately 5.3 and an osmolality of approximately 328 mOsm/kg. |
Each vial contains 920 mg of ocrelizumab in 23 mL (40 mg/mL).
Ocrelizumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Ocrelizumab is a recombinant humanised monoclonal antibody that selectively targets CD20-expressing B cells. The precise mechanisms through which ocrelizumab exerts its therapeutic clinical effects in MS is presumed to involve immunomodulation through the reduction in the number and function of CD20-expressing B cells. Following cell surface binding, ocrelizumab selectively depletes CD20-expressing B cells through antibody-dependent cellular phagocytosis (ADCP), antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and apoptosis. The capacity of B-cell reconstitution and preexisting humoral immunity are preserved. |
| List of Excipients |
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Recombinant human hyaluronidase (rHuPH20) |
23 mL of solution for injection in a vial (colourless Type I glass).
Pack size of 1 vial.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/17/1231/003
Date of first authorisation: 8 January 2018
Date of latest renewal: 21 September 2022
| Drug | Countries | |
|---|---|---|
| OCREVUS | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Nigeria, Netherlands, New Zealand, Poland, Romania, Tunisia, Turkey, United Kingdom, United States |
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