「9週まで」というのは９週と6日までOKなのでは？⇒末尾の後日談参照。9週と0日まででした。
以下は2003年の初版のWHO『安全な中絶』に出てくる図だ。
ここでは妊娠9週まるごと（まで）中絶薬を使用可能となっている。
ふと気が付いて、ラインファーマ社の「９週まで」というのが9週0日までなのか9週6日なのかどうかを確認した。
以下、Linepharma社の広告で確認した。
Linepharma International to Bring Medication Abortion Product to Japan – LinePharma
ANNOUNCEMENTS
Linepharma International to Bring Medication Abortion Product to Japan
POSTED ON MAY 6, 2021 BY DANA
Linepharma International, a leading provider of pharmaceuticals developed specifically for medication abortion, is pleased to confirm its intention to bring medication abortion products to Japan.Following successful clinical trials that showed the combination of mifepristone and misoprostol to be successful in terminating a pregnancy in 120 abortion-seeking women between the ages of 18 and 45, who were in the ninth week of their pregnancy or earlier, Linepharma hopes to bring the first pharmaceutical product for medication abortion to Japan.
Patients took one 200mg tablet of Mifepristone followed two days later with four 200mcg tablets of Misoprostol.
Results showed a high rate of success amongst Japanese women, over 93%, within 24 hours.
Professor of Obstetrics and Gynecology at the University of Tokyo, Yutaka Osuga oversaw the clinical trial and presented the results at an April conference of the Japan Society of Obstetrics and Gynecology.
Professor Osuga said the data was “either equating to or surpassing the data from overseas.” News of the clinical trial results came amid a growing need for access to sexual and reproductive health care around the world. “There has been a growing demand in Japan for abortion pills that are widely used and considered safe and effective around the world,” said Osuga.
If the drug is approved, the 156,430 Japanese women who had surgical abortion procedures in the year 2019 alone will have more options for abortion according to their own needs.
On the World Health Organization’s Essential Medicines List for the termination of a developing intra-uterine pregnancy, mifepristone was first approved in France in 1988 and has since been used regularly for abortion, along with misoprostol, in over 70 countries worldwide.
If approved, Linepharma’s product will be the first medication abortion pharmaceutical product in Japan.
For more information, please contact Linepharma:
LINEPHARMA INTERNATIONAL LIMITED
16 Upper Woburn Place
London, WC1H 0BS
United Kingdom
- 1 877 230 4227
contact@linepharma-nordicaffiliate-v1.dev.pulse.digital
本文を仮訳します。
アナウンスメント
リネファーマインターナショナル、薬用中絶製品を日本に導入へ
Posted on May 6, 2021 by dana
薬による中絶のために特別に開発された医薬品を提供するリーディングカンパニーであるLinepharma Internationalは、薬による中絶製品を日本に持ち込む意向を確認したことをお知らせします。妊娠9週目以前の18歳から45歳までの中絶希望女性120人を対象に、ミフェプリストンとミソプロストールの併用で妊娠を終了させることに成功した臨床試験を受け、リネファーマは、日本初の薬による中絶のための医薬品を日本に導入したいと考えています。
患者さんは、ミフェプリストン200mgを1錠服用し、2日後にミソプロストール200mcgを4錠服用しました。
その結果、日本人の女性の93％以上が24時間以内に成功したことが分かりました。
東京大学の大須賀裕教授（産婦人科）が臨床試験を担当し、4月の日本産科婦人科学会で発表しました。
大須賀教授は、"海外のデータと同等かそれ以上 "のデータが出ていると述べた。臨床試験結果のニュースは、世界中で性と生殖に関するヘルスケアへのアクセスに対するニーズが高まっている中で発表されました。"世界中で広く使用され、安全で効果的とされている中絶薬に対する日本での需要が高まっている "と大須賀は述べている。
本剤が承認されれば、2019年の1年間だけで、中絶手術を受けた15万6430人の日本人女性が、それぞれのニーズに応じた中絶手術の選択肢を増やすことができるようになるのです。
発育途上の子宮内妊娠の終了を目的とした世界保健機関の必須医薬品リストに掲載されているミフェプリストンは、1988年にフランスで初めて承認され、その後、ミソプロストールとともに世界70カ国以上で中絶のために常用されています。
承認されれば、リネファーマの製品は日本初の薬物中絶用医薬品となります。
詳細については、リネファーマにお問い合わせください。
やはり妊娠9週とそれより以前となっているので、9週と6日まで入ることが確認できた。
後日談：
2022年10月9日現在、Linepharma InternationalのMefeegoに関するページを開くと次のようになっている。"MEFEEGO™ for the medical termination of pregnancies of up to 63 days of gestation”つまり「妊娠63日までの医学的な妊娠の終了のためのMEFEEGO™」9週と0日までということになる。
ANNOUNCEMENTS
Linepharma International files for manufacturing, marketing approval of the abortion pill in Japan
POSTED ON JANUARY 5, 2022 BY DANA
LONDON and TOKYO, Dec. 22, 2021 /CNW/ – Linepharma International Ltd., a global leader in medical abortion, announced today that its subsidiary Linepharma KK has applied for manufacturing and marketing approval in Japan for its oral drug MEFEEGO™ for the medical termination of pregnancies of up to 63 days of gestation. The medication is recognized as the international gold standard for first trimester medical abortioni and is on the World Health Organization (WHO) list of essential drugs for abortion.iiA successful submission in Japan would signify the first approved medical abortion drug in Japan and would follow launches in Australia and Canada and most recently 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 outstanding safety record throughout the world.iii
The drug combination of mifepristone and misoprostol, the first combination pack worldwide, will be known in Japan as MEFEEGO™. The application to the Pharmaceuticals and Medical Devices Agency (PMDA) is based on the results of a Japanese Phase III clinical trial consisting of 120 women aged 18 to 45 years old. If the drug is approved, the 156,430 Japanese women who had surgical abortion procedures in 2019 alone will have another therapeutic option based on their individual need.
“Linepharma is a global pioneer in abortion medicine and is dedicated to improving sexual and reproductive health including the discovery, development and distribution of innovative health solutions including a combination abortion medication. 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”, said Marion Ulmann, Linepharma International’s General Manager. “Our drug application for MEFEEGO in Japan is a very significant milestone for Japanese women who, for the very first time, will have an entirely new option for abortion.”
Around 73 million induced abortions take place worldwide each year. Global estimates demonstrate that 45% of all induced abortions are unsafe.iv According to the WHO, abortion is a simple and safe healthcare 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 North and South America and the Asia-Pacific region. In line with the most current scientific data and World Health Organization’s recommendations, Linepharma supplies products for medication abortion in Canada, Latin America, Asia, and Australia. For more information visit www.linepharma.comLinepharma KK
Linepharma KK was established in May 2020 and acquired a 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 drug for the medical termination of pregnancy.
