Ipilimumab 50mg
| Product Overview | |
| Generic Name | Ipilimumab 50mg |
| Brand Name(s) | Yervoy® |
| Form | Intravenous infusion solution (concentrate for sol/infusion) |
| Strength | 50mg/10mL (5mg/mL) |
| Therapeutic Class | Immune checkpoint inhibitor (CTLA-4 blockade), antineoplastic immunotherapy |
| ATC Code | L01 FX04 |
| Manufacturing & Regulatory | |
| Manufacturer | BMS, |
| Country | USA |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | Pending |
| Free Sale Certificate | Available from supplier on request |
| Logistics & Export | |
| MOQ | 10 Vials |
| Shelf Life | 36 months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Manufacturer provides standard SDS (biologic/aqueous injectable) |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Ipilimumab is indicated for the treatment of unresectable or metastatic melanoma; in combination with nivolumab it is also indicated for renal cell carcinoma, non-small-cell lung cancer (first-line), hepatocellular carcinoma, malignant pleural mesothelioma, and microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer per regulatory approvals.
