Esmya (ulipristal acetate 5 mg): Withdrawal of product registration
Post date: Dec 15, 2020 1:55:27 AM
The National Pharmaceutical Regulatory Agency (NPRA) would like to inform healthcare professionals regarding the withdrawal of product registration of Esmya 5 mg tablet
(ulipristal acetate) [MAL15025044ACZ] by Zuellig Pharma Sdn. Bhd. in Malaysia and worldwide.
In April 2020, Esmya products have been recalled from the market in response to new safety concerns on the risk of liver injury associated with Esmya as highlighted by the European
Medicines Agency (EMA) pending a safety review. Cases of serious liver injury leading to liver transplantation following exposure to ulipristal acetate had occurred despite the implementation
of risk minimisation measures since 2018. Therefore, Esmya will no longer be available and women previously receiving Esmya should be advised on alternative therapy.
In Malaysia, Esmya was the only registered product containing ulipristal acetate 5 mg and it has been removed from our UMMC formulary.