Turoctocog alfa (Efmoroctocog Alfa)
| Product Overview | |
| Generic Name | Turoctocog alfa (Efmoroctocog Alfa) |
| Brand Name(s) | Novoeight |
| Form | Lyophilised powder, solvent for solution for intravenous injection single-dose vial |
| Strength | 1000 IU |
| Therapeutic Class | Antihaemorrhagic; blood coagulation factor VIII replacement therapy |
| ATC Code | B02BD02 |
| Manufacturing & Regulatory | |
| Manufacturer | Novo Nordisk A/S |
| Country | Denmark |
| GMP Compliance | WHO-GMP |
| DMF/CEP | No public DMF number located |
| COFEPRIS | 010.000.6064.00 |
| Free Sale Certificate | may obtain export certificate from regulatory authority |
| Logistics & Export | |
| MOQ | 10 Units |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, room temperature up to 30 °C for up to 12 months |
| Incoterms | EXW, HS 30021500 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| CTD Summary | available through EMA/FDA-style public documents, |
Description
Novoeight® (turoctocog alfa) is a recombinant human coagulation factor VIII product indicated for adults and children with haemophilia A for on-demand treatment and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce bleeding frequency.
Novoeight / NovoEight. Related but different molecule: Esperoct is turoctocog alfa pegol; Elocta/Eloctate is efmoroctocog alfa. 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU per vial
