Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: Mononine
Active substance: Human coagulation factor IX
Indication: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency)
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
16/12/2003 Referral EMEA/H/A-7(5)/525 (2003)5056 of 12/12/2003