The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the marketing authorisation of Teva Pharmaceutical’s Seasonique for prevention of pregnancy.
Seasonique (levonorgestrel (0.15mg)/ethinyl estradiol (0.03mg) and low-dose ethinyl estradiol (0.01mg) tablets) is a 91-day extended-regimen oral contraceptive that contains a combination of female hormones that prevent ovulation.
The CHMP concluded that the benefits of Seasonique outweigh its risks and that marketing authorisation should be granted in France and in the EU member states of Austria, Belgium, Germany, Italy, Poland, Romania, Slovakia and Slovenia.
CHMP recommends Teva’s pregnancy prevention drug
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the marketing authorisation of Teva Pharmaceutical’s Seasonique for prevention of pregnancy.
CHMP recommends Teva’s pregnancy prevention drughttp://www.pharmaceutical-technology.com/news/newschmp-recommends-tevaspregnancy-prevention-drug-4310517
