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Dear Doctor Letter (Rote-Hand-Brief) on ulipristal acetate (Esmya®): restricted indication, new contraindication and requirements for liver monitoring
2018.08.03
Active substance: Ulipristalacetat
Treatment with Esmya may carry a risk of serious liver injury. After finalisation of the corresponding referral procedure, the following new measures to minimise the risk of serious liver injury will be implemented from now on: restriction of indication, new contraindication and requirements for liver function monitoring.
For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):
Risikobewertungsverfahren zum Arzneimittel Esmya®
Download DHPC / Information letter , Download_VeroeffentlichtAm_EN