Bayer HealthCare (BYR.L, BAYRY.PK, BAYZF.PK) said it has submitted an application for marketing authorization in the European Union for a new transparent low dose contraceptive patch. France would serve as the reference member state in the decentralized procedure for gaining marketing authorization in countries in the European Union.
"Once approved and launched, our contraceptive patch will provide an additional choice among contraceptive methods especially for women who are looking for an aesthetic, convenient weekly transdermal application with a low hormonal dose," according to Flemming Ornskov, Chief Marketing Officer - Strategic Marketing General Medicine at Bayer HealthCare Pharmaceuticals.
The data from clinical trials, including 4,200 women globally, demonstrate that the new low dose contraceptive patch is an efficacious contraceptive with a good safety profile. The contraceptive patch is small, round and transparent and contains 0.55 mg ethinylestradiol and 2.1 mg gestodene.
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