This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Spain, Tunisia, Turkey, UK, United States.
The drug OCREVUS contains one active pharmaceutical ingredient (API):
1
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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. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| A6-100051 | Intravenous infusion | Ocrevus INJ_SOL 300mg/vial 110ml | Ocrevus Ocrelizumab Ocrelizumab 300mg/vial... Sodium Acetate Trihydrate, 21.4mg/vial......Glacial Actetic Acid, 2.5mg//vial.......... a , a - Trehalose dihydrate polysorbate ,400.0mg/via....polysorbate20, 2.0mg/vial... Water for Injection, QS 10.0ml/vial Vaccines & Biologicals Biologics Imported Products 110ml 07/10/2020 Roche Products Limited, 8th Floor, Roche Office 21 Mobolaji Bank Anthony Way, Etiebet's Place, Ikeja. Lagos 8056292219 angela.essien@roche.com Roche Diagnostics GmbH, Mannheim Sandhofer Strasse 116 D-68305 Mannheim, Germany, Roche Diagnostics GmbH, Mannheim Sandhofer Strasse 116 D-68305 Mannheim, Germany, Germany | 24/05/2022 |
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| OCREVUS Concentrate for solution for infusion | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | 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) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 11237K, 11242Q |
| BR | Câmara de Regulação do Mercado de Medicamentos | 529218060027101 |
| CA | Health Products and Food Branch | 02467224 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 126-MBE-0418 |
| EE | Ravimiamet | 1762422, 1762433 |
| ES | Centro de información online de medicamentos de la AEMPS | 1171231001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 405139 |
| FR | Base de données publique des médicaments | 66127361 |
| GB | Medicines & Healthcare Products Regulatory Agency | 350585, 354242 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 8347 |
| IT | Agenzia del Farmaco | 045889019, 045889021 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1084789, 1084790 |
| NG | Registered Drug Product Database | A6-100051 |
| NL | Z-Index G-Standaard, PRK | 149322 |
| NZ | Medicines and Medical Devices Safety Authority | 18432 |
| PL | Rejestru Produktów Leczniczych | 100399341 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W64485001 |
| TN | Direction de la Pharmacie et du Médicament | 6993221H |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699505761954, 8699505761978 |
| US | FDA, National Drug Code | 50242-150 |
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