07.01.2021 - Hearing within the graduated plan procedure (“Stufenplanverfahren”)

Reporting pregnancies via special file number
Affected active substances here: Acitretin, alitretinoin, isotretinoin (oral use)

The BfArM requires pharmaceutical companies to report annually all pregnancies reported in connection with the use of acitretin, alitretinoin and isotretinoin.

05.09.2019 - Amendment to the notice of 16 July 2018

With reference to its notice of 16 July 2018 and the amendments of the Ordinance on the Prescription of Medicinal Products (Verordnung über die Verschreibungspflicht von Arzneimitteln, AMVV), the Federal Institute for Drugs and Medical Devices (BfArM) has issued an amendment to the notice on orally administered medicinal products containing the active substances acitretin, alitretinoin and isotretinoin.

20.07.2018 - Notice within the graduated plan procedure ("Stufenplanverfahren")

The Federal Institute for Drugs and Medical Devices (BfArM) is realising the EU Commission's implementing decision. This concludes the European Safety Review on retinoids in accordance with Article 31 of Directive 2001/83/EC.

23.03.2018 - CMDh expertise

As a result of the CHMP's opinion, the European Medicines Agency EMA has concluded its assessment of retinoids and confirms that it is necessary to update the measures for pregnancy prevention and to include a warning in the product information regarding the possible risk of neuropsychiatric disorders (such as depression, anxiety and mood changes) for oral retinoids.

09.02.2018 - PRAC recommendation

The Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of medicinal products containing retinoids. PRAC recommends updating measures for pregnancy prevention during retinoid use. In addition, a warning regarding possible risks of neuropsychiatric disorders was included for all oral retinoids.

14.07.2016 - Procedure started

The BfArM issues information on the initiation of a European safety review regarding retinoids. The active substances concerned are taken orally or cutaneously for treatment of several skin conditions and certain forms of cancer. The safety review has been initiated in order to scientifically reevaluate the measures for pregnancy prevention and for minimising the possible risk of neuropsychiatric disorders.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):