Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use

Leflunomide Apotex

Product name: Leflunomide Apotex
Also marketed in the EU under the name(s): Leflunomid Apotex, Leflunomida Apotex
Active substance: leflunomide
Indication: Treatment of adults with active moderate to severe rheumatoid arthritis and psoriatic arthritis.
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
04/12/2012 Referral EMEA/H/A-31/1340 (2012)9091 of 30/11/2012