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.
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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’s positive opinion for Seasonique is supported by data from clinical trials and real-world experience. Data showed that when informed that monthly menses is not medically necessary while on the pill, seven out of ten women prefer to have fewer periods a year.
A global survey of women in the US, Brazil and Germany indicated that a majority of respondents stated a preference to have just four periods a year.
Seasonique EU study investigator Rossella Nappi said: "Women now starting on oral hormonal contraceptive will be able to choose to have a monthly menstrual period or not."
Teva received approval for Seasonique in the US in 2006, in Chile in November 2013, and in Brazil in April 2014.
