February 21, 2018 / 3:15 PM / 5 months ago

BRIEF-Richter's Esmya has favourable benefit-risk balance - EMA

Feb 21 (Reuters) - European Medicines Agency (EMA) says in Assessment report on provisional measures about uterine fibrosis drug of Hungary’s Richter:

* RICHTER’S ESMYA UTERINE FIBROSIS DRUG’S BENEFIT-RISK BALANCE “REMAINS FAVOURABLE SUBJECT TO THE AGREED PROVISIONAL MEASURES”

* EMA RECOMMENDS VARIATIONS OF THE TERMS OF THE MARKETING AUTHORISATION FOR ESMYA

* EMA COMMITTEE SAYS RECOMMENDATION IS WITHOUT PREJUDICE TO THE FINAL CONCLUSIONS OF ONGOING PROCEDURE REGARDING ESMYA Source text for Eikon: [here ] Further company coverage: (Reporting by Marton Dunai)

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