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HGF遺伝子治療用製品「コラテジェン」の製造承認申請取り下げにともなう販売終了についてNEW

Regarding the discontinuation of sales due to the withdrawal of the manufacturing approval application for the HGF gene therapy product 'Collategene' NEW.

Mitsubishi Chemical Group ·  Jun 23 23:00

Tanabe Mitsubishi Pharmaceutical Co., Ltd. (Headquarters: Chuo-ku, Osaka City, Representative Director: Akihiro Tsujimura, hereinafter referred to as 'Tanabe Mitsubishi Pharma') of Mitsubishi Chemical Group announces that the sale of the HGF gene therapy product 'Colategen, 4mg/muscle injection' (hereinafter referred to as 'Colategen') will be discontinued due to the withdrawal of the manufacturing approval application by AnGes, Inc. (Headquarters: Ibaraki City, Osaka Prefecture, President and Representative Director: Hideo Yamada, hereinafter referred to as 'AnGes'), the manufacturer and distributor of the product.As a result of AnGes withdrawing their manufacturing approval application, the expiration of the current limited approval and the termination of sales of Colategen, a product that has been sold by Tanabe Mitsubishi Pharmaceutical based on the conditions and limited manufacturing and sales approval in Japan by AnGes since September 2019. Furthermore, as a result, Tanabe Mitsubishi Pharmaceutical will recall the product from the market (Class II), but it is not related to a product recall that affects quality and safety. There is no risk of health damage resulting from the incident that caused this recall.Please note that announcements of individual stocks should be made via Futubull account.

Collagen is a product sold by Tanabe Mitsubishi Pharmaceutical based on domestic manufacturing and marketing approval with conditions and deadlines by Anjes, since September 2019. Following the withdrawal of Anjes' application for manufacturing approval to be submitted after the conditional and time-limited approval, the current conditional and time-limited approval has expired and sales will end.Collagen is a product sold by Tanabe Mitsubishi Pharmaceutical based on domestic manufacturing and marketing approval with conditions and deadlines by Anjes, since September 2019. Following the withdrawal of Anjes' application for manufacturing approval to be submitted after the conditional and time-limited approval, the current conditional and time-limited approval has expired and sales will end.
Furthermore, as a result, Tanabe Mitsubishi Pharmaceutical will recall the product from the market (Class II), but it is not related to a product recall that affects quality and safety. There is no risk of health damage resulting from the incident that caused this recall.

Contact

Mitsubishi Chemical Group Public Relations Department Osaka Communication Department TEL: 06-6205-5119

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