International
LINEPHARMA INTERNATIONAL FILE FOR PRODUCTION, APPROVAL OF ABORTION MARKET MARKETING IN JAPAN
London AND Tokyo, December 22, 2021 / PRNewswire / – Linepharma International Ltd., a global leader in medical abortion, announced today that its subsidiary Linepharma KK has applied for production and marketing approval in Japan for its oral medicine MEFEEGO for medical termination of pregnancies up to 63 days of pregnancy. The drug is recognized as the international gold standard for medical abortion in the first trimesterofand is on the World Health Organization (WHO) list of essential drugs for abortion.of secondment
A successful appearance at Japan would mean the first drug approved for medical abortion in Japan and would follow the omissions in Australia AND Canada and finally in South Korea, where a submission to health authorities will be made later this year. Available in 80 countries, the abortion pill has maintained an extraordinary safety record worldwide.iii
The combination of mifepristone and misoprostol, the first worldwide combination package, will be recognized in Japan si MEFEEGO. Application to the Agency for Pharmaceuticals and Medical Devices (PMDA) is based on the results of a Japanese Phase III clinical trial consisting of 120 women aged 18 to 45 years. If the drug is approved, 156,430 Japanese women who had undergone surgical abortion procedures in 2019 alone will have another therapeutic option based on their individual needs.
“Linepharma is a global pioneer in abortion medicine and is committed to improving sexual and reproductive health including discovering, developing and delivering innovative health solutions including a combined abortion medicine. We are equally committed to working closely “with health regulators, healthcare professionals, patient groups and other stakeholders to ensure access to safe and effective options.” Marion Ulmann, General Manager of Linepharma International. “Our drug application for MEFEEGO at Japan “It’s a very significant milestone for Japanese women who, for the first time, will have a whole new opportunity for abortion.”
About 73 million abortions occur worldwide each year. Global estimates show that 45% of all induced abortions are unsafe.iv According to the WHO, abortion is a simple and safe health care intervention that can be effectively managed by a wide range of healthcare professionals using medication or a surgical procedure.v
About Linepharma International Ltd.
Linepharma International Ltd. was established in 2010 and currently operates in more than 25 countries in the north and South America AND Asia-Pacific Region. In line with the latest scientific data and recommendations of the World Health Organization, Linepharmasurnizon products for abortion drugs in Canada, Latin America, Asia, and Australia. For more information visit www.linepharma.com
Linepharma KK
Linepharma KK was established in May 2020 and has obtained the license as a pharmaceutical company in July 2021. Linepharma KK is committed to improving women’s health through products and solutions focused on unmet medical needs, including an oral medicine for medical termination of pregnancy.
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ofJOGC 2019 Barriers and Facilitators for Implementing First Trimester Medical Abortion with Mifepristone in Qubec Province: A Qualitative Investigation Marie-Soleil Wagner, MD, MS; Sarah Munro, PhD; Elizabeth S. Wilcox, MA; Courtney Devane, RN, MN; Wendy V. Norman, MD, MH Sc; Sheila Dunn, MD, MSc; Judith A. Soon, RPh, PhD; Edith Guilbert, MD, MSc |
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of secondmentwww.who.int/news-room/fact-sheets/detail/abortion |
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iiiwww.actioncanadashr.org/resources/factsheets-guidelines/2019-04-06-faq-abortion-pill-mifegymiso |
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ivBearak J, Popinchalk A, Ganatra B, Moller AB, Tunalp, Beavin C et al. Unwanted pregnancy and abortion by income, region and legal status of abortion ratings from a comprehensive model for 19902019. Lancet Glob Health. September 2020; 8 (9): e1152-e1161. doi: 10.1016 / S2214-109X (20) 30315-6 |
BURIMI Linepharma International Limited
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