Alhemo (concizumab)
- Region
- 🇪🇺 EU
- Active substance
- concizumab
- Company
- Novo Nordisk A/S
- Status
- Authorised
- Therapeutic area
- Hemophilia A; Hemophilia B
- CHMP opinion
- Thu 17 Oct 2024
- EU approval
- Fri 13 Dec 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005938
- ATC
- B02BX10
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.