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EMA Panel Finalises Safety Probe Into Richter’s Fibroid Drug Esmya

Executive Summary

Gedeon Richter’s uterine fibroid drug, Esmya (ulipristal acetate), is expected to be the subject of a safety recommendation by the EMA’s pharmacovigilance committee this week.

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Richter Expects Esmya Sales To Drop 50% Following EU Restrictions Over Liver Concerns

Restrictions placed on the use of Gedeon Richter’s uterine fibroid drug Esmya by the European Medicines Agency could significantly dent the product’s sales in the EU, and could also have a knock-on effect in the US, where the FDA accepted an NDA filing for the drug in October 2017.

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