08.04.2020 - Notice within the graduated plan procedure ("Stufenplanverfahren")

The PRAC recommendations were adopted by the CMDh by consensus on 30 January 2020. The Federal Institute for Drugs and Medical Devices (BfArM) has implemented the decision at national level by official notice, dated 18 March 2020.

17.01.2020 - PRAC confirms recommendation after renewed review

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) confirmed its recommendation to limit the use of high-strength creams containing 100 micrograms/gram (0.01%) of estradiol to a single treatment period of up to 4‑weeks.

07.10.2019 - PRAC recommendation

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended that the use of high-dose creams containing 100 micrograms/g (0.01%) estradiol be limited to a single treatment period of up to 4 weeks.

12.04.2019 - Procedure started

BfArM informs about the initiation of a European risk assessment procedure according to Art. 31 of the Directive 2001/83/EC for estradiol-containing medicinal products.

Further information

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

To the risk assessment procedure (available in German only)