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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
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially COPAXONE®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents); the possibility of
material fines, penalties and other sanctions and other adverse
consequences arising out of our ongoing FCPA investigations and related
matters; our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent and
during the timeframe intended by our cost reduction program; our ability
to identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; increased government scrutiny in both the U.S. and
Source:
Teva Pharmaceutical Industries Ltd.
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