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| July 04, 2014 2:00 a.m. |
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| Teva Receives CHMP Positive Opinion for Seasonique® Extended-Regimen Contraceptive for Marketing Authorization in Several European Countries |
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An Extended Regimen Oral Contraceptive That Provides Quarterly Menses
– A New Concept for Women in
Seasonique® is an extended regimen birth control option that contains 84 active pills made up of levonorgestrel/ethinyl estradiol and is followed by seven days of ethinyl estradiol tablets. The ethinyl estradiol tablets are used during the seven days, instead of a placebo interval, allowing women to have four scheduled periods a year and potentially lessening the withdrawal symptoms that result from a sudden, sharp decrease in hormones. Seasonique® is backed by extensive clinical trials and real-world experience, and is more than 99 percent effective when taken as directed.
“Seasonique’s approval will allow physicians to prescribe their patients
an oral contraceptive that offers less frequent menses and is both safe
and effective," noted
Data demonstrate that when informed that monthly menses is not medically
necessary while on the pill, seven out of 10 women prefer to have fewer
periods a year. In fact, a global survey of women in the U.S.,
“Teva is pleased with the EMA’s CHMP opinion which allows Seasonique®
to be accessible to more women throughout the world,” said
Seasonique® has been available in About Seasonique® Seasonique® (levonorgestrel (0.15 mg)/ethinyl estradiol (0.03 mg) 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. Seasonique® is indicated for the prevention of pregnancy. Seasonique® tablets are taken daily for three months and each subsequent 91-day pack is started the day after the last tablet of the previous pack. About Teva
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Source:
Teva Pharmaceutical Industries Ltd.
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