BfArM - Federal Institute for Drugs and Medical Devices

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Acitretin and teratogenicity: Extension of the period of pregnancy prevention to 3 years after end of treatment

Active substance: Acitretin

The BfArM issues information on the result of the European PSUR worksharing procedure for the active substance acitretin. It was determined that the current 2-year period of pregnancy prevention after end of treatment is not sufficient and must therefore be extended to 3 years.

To the risk information - full text (available in German only)