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経口そう痒症改善剤「REMITCH OD Tablets 2.5µg」の インドネシアにおける承認取得に関するお知らせ

Announcements of individual stocks regarding the approval obtained in indonesia of the oral pruritus improvement agent "REMITCH OD Tablets 2.5µg"

Toray Industries ·  Sep 24 11:00

Meiji Seika Pharma, headquartered in Chuo-ku, Tokyo, with President Daikichiro Kobayashi, and Toray Industries Inc., headquartered in Chuo-ku, Tokyo, with President Mitsuo Oya, announce that PT. Meiji Indonesia Pharmaceuticals Industries, an overseas subsidiary of Meiji Seika Pharma based in Jakarta and led by President Ryo Takigawa, obtained import approval for the sale of the oral antipruritic agent "REMITCH OD Tablets 2.5µg" (generic name: Nalfurafine hydrochloride) in Indonesia in August, for the indication of pruritus improvement in dialysis and chronic liver disease patients (limited to cases where the existing treatment is insufficient).

"REMITCH OD Tablets 2.5µg" is marketed in Japan as "Remitch OD Tablets 2.5µg" *, and is sold with the indication of pruritus improvement in dialysis and chronic liver disease patients (limited to cases where the existing treatment is insufficient). Meiji Seika Pharma and Toray signed a contract in January 2019 for the development and sale of "REMITCH OD Tablets 2.5µg" in Thailand and Indonesia, and have been progressing with the development in both countries. In Indonesia, an import approval application was submitted to the Indonesian National Agency of Drug and Food Control in March 2022, and approval has now been obtained. PT. Meiji will be responsible for sales and information provision activities. In Thailand, in June 2023, Thai-Meiji Pharmaceuticals Co., Ltd. obtained import approval for the indication of skin pruritus improvement in hemodialysis patients (limited to cases where the existing treatment is insufficient) from the Thai Department of Health, Ministry of Insurance, and Food and Drug Administration and has started sales and information provision activities this year.

Meiji Seika Pharma and Toray will contribute to reducing the pruritus of dialysis patients and chronic liver disease patients with insufficient effect from existing treatments through the sales and information provision activities of "REMITCH OD Tablets 2.5µg".


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(※) "Remitch OD Tablet"
Remitch is the world's first selective opioid κ (kappa) receptor agonist developed by Toray.
Remitch OD Tablets can be taken with or without water, leading to improved medication adherence for patients who need to restrict water intake.
Remitch is a registered trademark of Torii Pharmaceutical Co., Ltd.

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