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Positive Ad Comm opinion for Teva's Seasonique

  • The EMA's Committee for Medicinal Products for Human Use issues a positive opinion regarding the marketing authorization of Teva's (TEVA) extended-regimen oral contraceptive Seasonique (levonorgestrel/ethinyl estradiol). The committee's positive vote clears the way to a product launch in selected European countries by the end of this year.
  • Seasonique is a regimen that contains 84 active pills comprised of levonorgestrel/ethinyl estradiol followed by seven days of ethinyl estradiol tablets. These are used in the seven day regimen instead of placebo to allow women to have four scheduled periods per year while lessening the withdrawal symptoms caused by a sudden drop in hormones.
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