Emicizumab 30mg
| Product Overview | |
| Generic Name | Emicizumab 30mg |
| Brand Name(s) | HEMLIBRA® ( |
| Product Type | Biosimilar |
| Form | Solution for injection, sub-C, single-dose vial |
| Strength | 30mg/mL /1.0mL SC |
| Therapeutic Class | Routine prophylaxis to prevent/reduce bleeding in hemophilia A |
| ATC Code | B02BX06 |
| Manufacturing & Regulatory | |
| Manufacturer | other |
| Country | India, Mexico |
| GMP Compliance | WHO-GMP |
| COFEPRIS | 010.000.6199.00 |
| Free Sale Certificate | Potentially available depending on exporting jurisdiction |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | Refrigerated (2–8 °C) |
| Incoterms | EXW, HSN 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Typically available as batch/lot CoA |
| CTD Summary | Public FDA/EMA label/SmPC available; full CTD is not public |
Description
Molecule: Emicizumab is a subcutaneous prophylaxis to prevent or reduce bleeding in hemophilia A patients
Presentation: 30 mg/1 mL solution for subcutaneous injection, single-dose vial
