Eculizumab 300mg
Product Overview
| Generic Name | Eculizumab 300mg |
| Brand Name(s) | Soliris, Bkemv, Epysqli |
| Category | Antineoplastic / Cancer |
| Form | concentrate for solution for infusion (IV use) single-dose vial |
| Strength | 300 mg/30 mL (10 mg/mL) |
| Therapeutic Class | Terminal complement (C5) inhibitor monoclonal antibody |
| ATC Code | L04AJ01 |
Manufacturing & Regulatory
| Manufacturer | Alexion, Amgen |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | medicamento huérfano |
| Free Sale Certificate | Available per batch upon request |
Logistics & Export
| MOQ | 10 Vials |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Supplied per batch upon request |
| SDS-Safety Data Sheet (PDF) | Available from manufacturer |
| CTD Summary (PDF) | CTD from originator; generic use abbreviated formats |
Special Notes
Eculizumab is a C5 complement inhibitor indicated for PNH (hemolysis reduction), aHUS (inhibition of complement-mediated TMA), AChR-positive refractory gMG in adults, and AQP4-positive NMOSD.