Eptacog alfa (recombinant coagulation factor VIIa / rFVIIa)
| Product Overview | |
| Generic Name | Eptacog alfa (recombinant coagulation factor VIIa / rFVIIa) |
| Brand Name(s) | NovoSeven RT |
| Form | Powder and solvent for solution for injection |
| Strength | 1 mg / 50 KUI |
| Therapeutic Class | Recombinant activated coagulation factor VII / bypassing haemostatic agent |
| ATC Code | B02BD08 |
| Manufacturing & Regulatory | |
| Manufacturer | Novo Nordisk A/S |
| Country | Denmark |
| GMP Compliance | WHO-GMP |
| DMF/CEP | No public DMF number located |
| COFEPRIS | 010.000.4250.02.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 36 months |
| Storage | Store below 25 °C, protect from light |
| Incoterms | EXW, HS 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| CTD Summary | CTD from originator; generic use abbreviated formats |
Description
Eptacog alfa activated is a recombinant activated factor VII product used as a bypassing haemostatic agent for treatment of bleeding episodes and perioperative bleeding prevention in patients with haemophilia A or B with inhibitors, acquired haemophilia, congenital factor VII deficiency, and Glanzmann’s thrombasthenia with platelet-transfusion refractoriness
