EMA Safety Commission Recommends Withdrawal Of Esmya Authorizations

Follows March Suspension By EMA

Marketing authorizations for Gedeon Richter’s Esmya and generic versions are certain to be revoked, after a review by the EMA’s safety committee concluded that the uterine fibroids drug “can cause liver injury, including the need for liver transplantation.”

EU Brussels
The PRAC recommendation will now be forwarded to EMA’s CHMP • Source: Shutterstock

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