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SOH-075 is an emergency contraceptive pill used after unprotected sex,
containing only levonorgestrel as an active ingredient. It inhibits
pregnancy before the implantation of the egg in the uterus by several
mechanisms involving changes to the uterine lining. It is not a
controversial pregnancy termination pill, but a helpful opportunity for
post-coital contraception. The first dose is taken within 72 hours after
unprotected sex and the second 12 to 24 hours later.
This product was developed by Laboratoires HRA Pharma as Norlevo®
and the exclusive distribution rights for Japan, Australia and New
Zealand were licensed to Sosei in April 2001. It was first launched in Europe in 1999 and is currently approved in some 60 countries. In December 2005, Sosei licensed the marketing right in Australia to Sandoz Pty Ltd. which now markets Norlevo in Australia.
In July 2008, phase III trials designed to evaluate the safety and prevented pregnancy rate of SOH-075 in Japanese adult female subjects who require emergency contraception was completed. No serious adverse events were reported during the study.
Further announcement will be made when all study results are fully analysed.
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