Ocrelizumab 300mg
| Product Overview | |
| Generic Name | Ocrelizumab 300mg |
| Brand Name(s) | Ocrevus |
| Form | Concentrate for solution for IV infusion (vial); SC solution |
| Strength | IV: 300 mg/10 mL (30 mg/mL) |
| Therapeutic Class | Immunosuppressant; B-cell–depleting anti-CD20 mAb for multiple sclerosis |
| ATC Code | L04AG08 |
| Manufacturing & Regulatory | |
| Manufacturer | Roche Registration GmbH, |
| Country | Germany, USA |
| GMP Compliance | WHO-GMP |
| DMF/CEP | U.S. approval under BLA 761053 |
| COFEPRIS | 010.000.6204.00 |
| Free Sale Certificate | Available per batch upon request |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | GHS-compliant SDS available upon commercial agreemeent |
| CTD Summary | Full CTD dossier proprietary; available under commercial agreement/license |
Description
Ocrelizumab is a humanized anti-CD20 monoclonal antibody indicated for adults with relapsing forms of multiple sclerosis (RMS) and primary progressive MS (PPMS).
