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Alvogen Targets Esmya With First European Rival

Executive Summary

Alvogen has gained European approvals for a rival to Gedeon Richter’s Esmya through the decentralized procedure.

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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.”

Gedeon Richter Sees Profit Jump By 40%

A strong tailwind from antipsychotic drug Vraylar helped Hungary’s Gedeon Richter to post a 40% leap in 2019 net profit. Analysts see more upside ahead for eastern Europe’s largest drugmaker.

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