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Ulipristal acetate 5 mg: temporary suspension of marketing authorisation for medicinal products for the treatment of uterine fibroids
2021.02.02
Active substance: ulipristal acetate
02.02.2021 - Notice within the graduated plan procedure
The Federal Institute for Drugs and Medical Devices (BfArM) has revoked the temporary suspension and ordered changes to the marketing authorizations for medicinal products containing ulipristal acetate 5 mg for the treatment of uterine fibroids.
13.11.2020 - CHMP opinion
EMA’s human medicines committee (CHMP) has recommended restricting use of medicines containing ulipristal acetate 5 mg (Esmya and generic medicines) as a result of cases of serious liver injury.
04.09.2020 - PRAC recommendation
PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids.
27.04.2020 - Notice within the graduated plan procedure ("Stufenplanverfahren") (Reference: EU Commission decision on Esmya®)
The Federal Institute for Drugs and Medical Devices (BfArM) has ordered the temporary suspension of marketing authorisations.
07.04.2020 - Hearing within the national graduated plan procedure ("Stufenplanverfahren") (Reference: EU Commission decision on Esmya®)
Hearing in the national graduated plan procedure ("Stufenplanverfahren") in order to suspend generic marketing authorisations temporarily
13.03.2020 - PRAC recommendation
Temporary suspension of marketing authorisation for medicinal products for the treatment of uterine fibroids
Further information
Details on the procedure can be found on the website of the European Medicines Agency (EMA):