February 9, 2018 / 12:12 PM / 6 months ago

BRIEF-EU health agency imposes temporary restrictions on Richter's Esmya medicine

Feb 9 (Reuters) - Richter Gedeon Vegyeszeti Gyar Nyrt :

* EUROPEAN MEDICINES AGENCY SAYS RECOMMENDS REGULAR LIVER MONITORING FOR WOMEN TAKING HUNGARIAN DRUGMAKER RICHTER’S ESMYA FOR UTERINE FIBROIDS WHILE ITS REVIEW IS ONGOING

* EMA SAYS MEASURE IS TEMPORARY WHILE ITS REVIEW IS ONGOING

* ALL WOMEN TAKING ESMYA SHOULD HAVE A LIVER FUNCTION TEST AT LEAST ONCE A MONTH DURING TREATMENT -EMA

* IF THE TEST IS ABNORMAL, THE HEALTHCARE PROFESSIONAL SHOULD STOP TREATMENT AND CLOSELY MONITOR THE PATIENT

* EUROPEAN MEDICINES AGENCY SAYS NO NEW PATIENTS SHOULD START TREATMENT AND NO PATIENTS WHO HAVE COMPLETED A COURSE OF TREATMENT SHOULD START ANOTHER ONE FOR THE TIME BEING

* RECOMMENDATIONS ARE TEMPORARY MEASURES TO PROTECT PATIENTS’ HEALTH, PENDING THE CONCLUSION OF THE REVIEW OF ESMYA

* RICHTER SHARES DOWN 1.7 PCT AT 6,295 FORINTS ON BUDAPEST STOCK EXCHANGE, OFF EARLIER LOWS BUT STILL UNDERPERFORMING Further company coverage: (Reporting by Gergely Szakacs)

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