News
CHMP extends the indication of Refixia to prophylaxis of bleeding in patients 12 years and above with haemophilia B
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Refixia.
The marketing authorisation holder for this medicinal product is Novo Nordisk A/S. The CHMP adopted an extension to an existing indication as follows: Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia B (congenital factor IX deficiency).Refixia can be used for all age groups.
Condition: Haemophilia B
Type: drug
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