The Japanese Ministry of Health, Labour and Welfare (MHLW), has granted marketing approval for Bayer Schering Pharma's long-acting intrauterine contraceptive system Mirena.

The product is expected to be launched in Japan in April 2007 under the trade name Mirena 52mg and will significantly enhance the choice of methods of contraception available to women in Japan.

"In Japan there has been a limited choice in convenient, reliable and reversible long-acting contraception" said Phil Smits, Head of Women's Healthcare at Bayer Schering Pharma AG. "We are delighted that with Mirena we can offer women in Japan an innovative long-acting method for contraception. With the Mirena launch in Japan we will further strengthen our leading position on the Japanese market and grow our worldwide leadership in female contraception".

The approval is based on broad experience from international studies as well as a Japanese study programme, including a large clinical trial with more than 400 Japanese women. Until now, Mirena has been used by more than 10 million women worldwide and is registered in more than 100 countries. With the approval in Japan, Mirena is now available in all major pharmaceutical markets worldwide.

Mirena, a levonorgestrel-releasing intrauterine contraceptive system (IUS), is marketed in many countries throughout the world. Mirena offers advantages to other birth control options, in particular compared to conventional intrauterine devices (IUDs). In addition to preventing pregnancy effectively over a period of five years, many women experience shorter, lighter and less painful periods while using Mirena.