Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Liver Damage Worries Lead To Further EU Restrictions On Richter’s Esmya

Executive Summary

The European Medicines Agency’s pharmacovigilance committee has recommended more restrictions on the use of Richter’s Esmya because of concerns over the risk of serious liver damage.

You may also be interested in...



EMA Safety Panel Recommends Withdrawing Esmya Authorizations

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

EMA Safety Commission Recommends Withdrawal Of Esmya Authorizations

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 Suspends Ulipristal Pending Further Review

Gedeon Richter's Esmya should not be prescribed to women while the European Medicines Agency again reviews the risk of serious hepatic injury.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS123140

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel