Marketing authorisation holders of medicinal products containing retinoids shall provide information on updates on teratogenicity and neuropsychiatric diseases. Retinoids are strongly teratogenic and must not be used during pregnancy. When oral retinoids are used in women of childbearing age, all conditions of the contraceptive programme must be met.

The educational materials for oral acitretin, alitretinoin and isotretinoin as part of the contraceptive programme will be sent at the same time as the "Dear Doctor Letter".

Educational material (available in German only)

To the risk assessment procedure:

Risikobewertungsverfahren Retinoide