Innovative long-acting contraceptive approved in Japan
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.
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.
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.
Mirena, a levonorgestrel-releasing intrauterine contraceptive system, offers advantages over conventional intrauterine devices, according to Bayer Healthcare. Mirena does not contain estrogen; instead it delivers a low dose of the progestin levonorgestrel (approx. 20µg/day) to the lining of the uterus and thereby provides desired local effects and minimises undesired systemic effects. Once Mirena is removed, fertility is rapidly restored.
'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. 'We are delighted that with Mirena we can offer women in Japan an innovative long-acting method for contraception.