Avelumab 200mg
| Product Overview | |
| Generic Name | Avelumab 200mg |
| Brand Name(s) | Bavencio® |
| Form | Concentrate for solution for intravenous infusion |
| Strength | 200 mg/10 mL (20 mg/mL) |
| Therapeutic Class | PD-L1–blocking monoclonal antibody (immune checkpoint inhibitor), antineoplastic |
| ATC Code | L01FF04 |
| Manufacturing & Regulatory | |
| Manufacturer | Merck KGaA/EMD Serono, Pfizer, Merck LTD |
| Country | Germany, USA |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | Registered in Mexico, Batch-specific specific clave unknown |
| Free Sale Certificate | Available from supplier on request |
| Logistics & Export | |
| MOQ | 5 units |
| 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 | Upon Request, not publicly posted |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Avelumab is a human IgG1 monoclonal antibody targeting PD-L1, used as an immune checkpoint inhibitor in oncology. It is indicated (region-specific) for: metastatic Merkel cell carcinoma (MCC)
