CHMP extends the indication of Refixia to prophylaxis of bleeding in patients 12 years and above with haemophilia B – Novo Nordisk

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.