Teva Pharmaceutical Industries Limited (TEVA) Receives CHMP Positive Opinion For Seasonique® Extended-Regimen Contraceptive For Marketing Authorization In Several European Countries
7/7/2014 11:35:28 AM
JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion in a referral procedure regarding the authorization of its extended-regimen oral contraceptive, Seasonique® (levonorgestrel (0.15 mg)/ethinyl estradiol (0.03 mg) and low-dose ethinyl estradiol (0.01 mg) tablets) for the prevention of pregnancy. The CHMP concluded that the benefits of Seasonique® outweigh its risks clearing the way for Seasonique®’s approval by local health authorities of the European Union (EU) Member States and launch in select countries throughout Europe by the end of 2014.
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