🇪🇺 ALHEMO in European Union

EMA authorised ALHEMO on 13 December 2024

Marketing authorisation

EMA — authorised 13 December 2024

  • Application: EMEA/H/C/005938
  • Marketing authorisation holder: Novo Nordisk A/S
  • Local brand name: Alhemo
  • 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.
  • Status: approved

The European Medicines Agency (EMA) approved Alhemo, a treatment for bleeding prophylaxis, on 13 December 2024. Alhemo is indicated for routine prophylaxis of bleeding in patients 12 years of age or more with haemophilia A (congenital factor VIII deficiency) and haemophilia B (congenital factor IX deficiency). This approval allows Novo Nordisk A/S to market Alhemo in the European Union under the local brand name Alhemo.

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ALHEMO in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in European Union

Frequently asked questions

Is ALHEMO approved in European Union?

Yes. EMA authorised it on 13 December 2024.

Who is the marketing authorisation holder for ALHEMO in European Union?

Novo Nordisk A/S holds the EU marketing authorisation.