US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| ALHEMO | 60MG/1.5ML(40MG/ML); 150MG/1.5ML(100MG/ML); 300MG/3ML(100MG/ML) | injectable · subcutaneous | NOVO NORDISK INC | Prescription | 20 Dec 2024 |
| ALHEMO | 60MG/1.5ML (40MG/ML); 150MG/1.5ML (100MG/ML); 300MG/3ML (100MG/ML) | solution · injection | NOVO NORDISK INC | Prescription | 31 Jul 2025 |
EMA European Union — centrally authorised medicines
Alhemo Novo Nordisk A/S · Authorised · authorised 13 Dec 2024 · ATC B02BX10
Therapeutic indication (EMA)
Alhemo is indicated for routine prophylaxis of bleeding in patients 12 years of age or more with: • haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors.• severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without FVIII inhibitors.• haemophilia B (congenital factor IX deficiency) with FIX inhibitors.• moderate/severe haemophilia B (congenital factor IX deficiency, FIX ≤ 2%) without FIX inhibitors.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.