This brand name is authorized in 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
The drug OCREVUS contains one active pharmaceutical ingredient (API):
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1
Ocrelizumab
UNII A10SJL62JY - OCRELIZUMAB
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| OCREVUS Concentrate for solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| L04AG08 | L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AG Monoclonal antibodies | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: AU | Pharmaceutical Benefits Scheme | Identifier(s): 11237K, 11242Q |
| Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 529218060027101 |
| Country: CA | Health Products and Food Branch | Identifier(s): 02467224 |
| Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 126-MBE-0418 |
| Country: EE | Ravimiamet | Identifier(s): 1762422, 1762433 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 1171231001 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 405139 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 66127361 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 350585, 354242 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8347 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 045889019, 045889021 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1084789, 1084790 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 149322 |
| Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 18432 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100399341 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W64485001 |
| Country: TN | Direction de la Pharmacie et du Médicament | Identifier(s): 6993221H |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699505761954, 8699505761978 |
| Country: US | FDA, National Drug Code | Identifier(s): 50242-150 |
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