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CHMP positive recommendation for a change to the marketing authorisation for Jivi (damoctocog alfa pegol) for haemophilia A - Bayer

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Published:29th Apr 2025

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Jivi. The CHMP adopted an extension to the existing indication to include treatment of children from 7 years of age, as follows. Treatment and prophylaxis of bleeding in previously treated patients ≥  7 years of age with haemophilia A (congenital factor VIII deficiency). Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Condition: Haemophilia A
Type: drug
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