Repros Therapeutics (RPRX) Submits MAA for Enclomiphene to EMA as Secondary Hypogonadism Treatment
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Repros Announces Submission of MAA to the European Medicines Agency for Enclomiphene in the Treatment of Secondary Hypogonadism
September 12, 2016 11:45 AM EDTUK designated as rapporteur and France as co-rapporteurAverage time to approval 13 16 months
THE WOODLANDS, Texas, Sept. 12, 2016 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq: RPRX) today announced that, as anticipated, it has activated the process for obtaining a marketing authorization (MAA) for enclomiphene in the treatment of secondary hypogonadism in Europe.
The MAA has been submitted today to the European Medicines Agency (EMA) by Renable Pharma Limited, the U.K. subsidiary of Repros.
The typical time from submission to authorization of a medicinal product through... More
