You are here:
High-dose creams containing estradiol: a new risk review
2020.04.08
Active substance: estradiol
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)