Nivolumab 40mg/4mL
| Product Overview | |
| Generic Name | Nivolumab 40mg/4mL |
| Brand Name(s) | Opdivo |
| Form | Intravenous solution vial; 10 mg/mL concentration |
| Strength | 40 mg/4 mL |
| Therapeutic Class | PD-1 immune checkpoint inhibitor |
| ATC Code | L01FF01 |
| Manufacturing & Regulatory | |
| Manufacturer | Bristol-Myers Squibb |
| Country | USA, India |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | Pending |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | Refrigerated (2–8 °C) |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Upon Request, not publicly posted |
| CTD Summary | Full CTD dossier proprietary; available under commercial agreement/license |
Description
Indications & Usage:Nivolumab (40 mg vial) is indicated as monotherapy or in combination for numerous advanced malignancies: unresectable/metastatic melanoma, NSCLC, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, MSI-H/dMMR colorectal cancer, hepatocellular carcinoma, esophageal/gastric/gastroesophageal junction cancers, among others
