New Intrauterine System for long-term contraception submitted for marketing authorization both in the EU and the U.S.

Bayer HealthCare has submitted an application for marketing authorization in the European Union and in the U.S. for a new low dose levonorgestrel releasing intrauterine system (IUS) for long-term contraception of up to three years. Sweden will serve as the reference member state in the decentralized procedure for gaining marketing authorization in the European Union.

The data from clinical studies, including women from North America, Latin America and several European countries, show that the new intrauterine system is an efficacious contraceptive with a good safety profile.

“Once approved our new low dose intrauterine system will be an excellent choice especially for young women who haven’t had children so far and who are looking for a reliable, convenient contraceptive option with a very low hormonal dose,” said Dr. Flemming Ornskov, Chief Marketing Officer – Strategic Marketing General Medicine at Bayer HealthCare.

The new intrauterine system has a small, flexible T-shaped plastic body that allows the controlled release of levonorgestrel at a low rate (initially 10 µg/day) for up to three years.
Compared to oral contraceptives, once approved the new IUS is a reliable contraceptive option for young women that does not require remembering to take a pill every day. It also offers rapid return to a woman’s usual level of fertility after removal.

To learn more about contraception, please visit: www.bayerpharma.de/contraception