Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Ocrevus 300 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion. Clear to slightly opalescent, and colourless to pale brown solution. |
Each vial contains 300 mg of ocrelizumab in 10 mL at a concentration of 30 mg/mL. The final drug concentration after dilution is approximately 1.2 mg/mL.
Ocrelizumab is a recombinant humanised anti-CD20 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ocrelizumab |
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 |
|---|
|
Sodium acetate trihydrate |
10 mL concentrate in a glass vial. Pack size of 1 or 2 vials. Not all pack sizes may be marketed.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
EU/1/17/1231/001
EU/1/17/1231/002
Date of first authorisation: 8 January 2018
| Drug | Countries | |
|---|---|---|
| OCREVUS | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Tunisia, Turkey, United Kingdom, United States |
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