Bayer Schering Pharma AG, Germany, has successfully concluded the European registration procedure for the introduction of Qlaira in the new indication treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception. The Netherlands served as Reference Member State for the decentralized procedure to gain Europe-wide Marketing Authorization for the new indication. Qlaira is the first in a new class of oral contraceptives to deliver estradiol, the same estrogen as the one produced by the female body. In addition, it also contains dienogest, a progestogen which is well-investigated. It has a unique dosing regimen which has been designed to deliver hormones at the right levels at the right time during the cycle. Qlaira is already marketed in over 25 European countries as an oral contraceptive.“We’re excited by today’s news regarding the new indication for Qlaira. Heavy menstrual bleeding is a serious though under-reported condition that significantly impacts on a woman’s quality of life. Qlaira can contribute to satisfy a high unmet medical need by offering women an oral treatment option that can lead to significant reduction in menstrual blood loss,” said Phil Smits, M.D., Head of Women’s Healthcare at Bayer Schering Pharma.
In addition to Qlaira, Bayer markets an intrauterine system Mirena® which is also approved for treatment of heavy menstrual bleeding (HMB). Both products underline Bayer´s ongoing commitment to advancing women’s healthcare by providing a choice of treatment options.
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