Teva Receives CHMP Positive Opinion for SeasoniqueВ® Extended-Regimen Contraceptive for Marketing Authorization in Several European Countries
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,
SeasoniqueВ® (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 SeasoniqueВ®
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.
SeasoniqueВ® 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.
About Biaxin (Clarithromycin) with free prescription SeasoniqueВ® 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 Rossella Nappi, Associate Professor of Obstetrics
and Gynecology, IRCCS Policlinico San Matteo, University of Pavia, Italy
and investigator in the SeasoniqueВ® EU study.
About Boniva (Ibandronae Sodium) with no prescription “Women now
starting on oral hormonal contraceptive will be able to choose to have a
monthly menstrual period or not.”
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.
Biaxin (Clarithromycin) without prescription In fact, a global survey of women in the U.S., Brazil
and Germany indicated that a majority of respondents stated a preference
to have just four periods a year.
“Teva is pleased with the EMA’s CHMP opinion which allows Seasonique®
to be accessible to more women throughout the world,” said Aine
Scibelli, Senior Director, Global Marketing Women s Health.
About Adesera “Many women
may not be aware that they can space their periods.
Buy Babies Vitamins online SeasoniqueВ®
will offer women a new choice in contraception to achieve greater
freedom and confidence in their birth control.”
SeasoniqueВ® has been available in the United States since
2006, where it gained 25 percent of the market share within two years,
and was approved in Chile on 28 November, 2013 and most recently in
Brazil on 14 April, 2014.
http://allegra-opinion.blogspot.com Upon approval, it is expected to be launched
in Austria, Slovakia and Poland with additional country launches to
follow.
About SeasoniqueВ®
SeasoniqueВ® (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. SeasoniqueВ® is
indicated for the prevention of pregnancy. SeasoniqueВ® 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
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world s
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in approximately 60 countries.
Teva s Specialty Medicines businesses focus on CNS, respiratory,
oncology, pain, and women s health therapeutic areas as well as
biologics. Teva currently employs approximately 45,000 people around the
world and reached $20.3 billion in net revenues in 2013.
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