The BfArM considers it necessary to add information on the risk of severe skin reactions to the product informations of medicinal products containing isotretinoin. This information was compiled by the Pharmacovigilance Working Party (PHVWP) of the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA). In a hearing under the graduated plan procedure (Stufenplan), stage II, the pharmaceutical manufacturers are requested to update their product informations and to confirm that they are in agreement with the conditions imposed for contraceptive measures.

(SPC - available in German only)

(package leaflet - available in German only)

zum Stufenplanverfahren

(graduated plan procedure - available in German only)