Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use


Product name: Isotretinoin
Also marketed in the EU under the name(s): Lurantal, Rexidal, Scheritonin, Trivane
Active substance: Isotretinoin
Indication: Severe forms of acne
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-29/497 (2003)3928 of 17/10/2003
19/05/2011 Referral EMEA/H/A-29/1276 (2011)3594 of 18/05/2011