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Pharmaceuticals - Community Register
List of nationally authorised medicinal products for human use
Mononine
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 procedures |
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 |