EU regulators okay Qlaira for the treatment of heavy menstrual bleeding

14-Oct-2010 - Germany

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.

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