Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: Roaccutane
Also marketed in the EU under the name(s): Roaccutan, Roacutan
Active substance: Isotretinoin
Indication: Not available
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
22/10/2003 Referral EMEA/H/A-30/499 (2003)3929 of 17/10/2003