Announcement of Approval to Manufacture and Market 5-HT3 (serotonin) receptor antagonist antiemetic agent 「Palonosetron I.V. Injection」, 「Palonosetron I.V. Infusion Bag」 in Japan

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15 February, 2021

Okayama Taiho Pharmaceutical Co., Ltd.

Helsinn Group

Okayama Taiho Pharmaceutical Co., Ltd. (hereafter “Okayama Taiho”, located in Bizen-city, Okayama, Japan, President: Minenobu Katayama) and Helsinn Group (“Helsinn”), a Swiss pharmaceutical group focused on building quality cancer care and rare diseases products, today announce Okayama Taiho has received the approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market 5-HT3 (serotonin) receptor antagonist antiemetic agent, Palonosetron I.V. injection 0.75mg/5mL 「TAIHO」 and Palonosetron I.V. infusion bag 0.75mg/50mL 「TAIHO」.

This product, licensed by Helsinn Healthcare SA to Okayama Taiho, is an authorized generic which has an identical formula, API, excipients, manufacturing process, facility, packaging materials, packaged pieces of the box, package size, except product name and package design, to the ALOXI® I.V. injection 0.75mg and I.V. infusion bag 0.75mg of which the MAH is Okayama Taiho’s affiliate Taiho Pharmaceutical Co., Ltd. (hereafter “Taiho”, Located in Chiyoda-ku, Tokyo, Japan, President: Masayuki Kobayashi).

Okayama Taiho will collaborate with Taiho to further contribute to patients and health care professionals.

Product Information

 

【Product name】

Palonosetron I.V. injection 0.75mg/5mL 「TAIHO」

Palonosetron I.V. infusion bag 0.75mg/50mL 「TAIHO」

【Generic name】

Palonosetron hydrochloride

【Indication】

Digestive symptoms (nausea or vomiting) (including delayed phase) resulting from the administration of antineoplastic agents (cisplatin, etc.)

【Dosage and Administration】

For intravenous and drip infusion use, the usual adult dosage of palonosetron is 0.75 mg per body once daily.

【Package】

Palonosetron I.V. injection 0.75mg/5mL 「TAIHO」       5mL x 5 Vials

Palonosetron I.V. infusion bag 0.75mg/50mL 「TAIHO」  50mL x 5 Bags

 

 

About Okayama Taiho Pharmaceutical

Okayama Taiho Pharmaceutical Co., Ltd.

Established

August 1, 1992

Head Office

1775-1 Kugui, Bizen-city, Okayama, Japan

President

Minenobu Katayama

Net sales (2019)

¥4,938M

Employees

172

Business Description

Manufacturing, distributing of pharmaceuticals and other related products

URL

https://www.okayama-taiho.co.jp/

 

  

About the Helsinn Group

Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has been improving the lives of patients, guided by core family values of respect, integrity and quality. The Group has an extensive portfolio of marketed innovative cancer and rare disease therapies, a robust drug development pipeline and ambitions to further accelerate its growth through in-licensing and acquisition to address unmet medical needs. Helsinn operates a unique integrated licensing business model, achieving success with long-standing partners in 190 countries, who share our values.

For more information, please visit:  https://www.helsinn.com/about-the-helsinn-group

 

The press release has been prepared in compliance with the Japanese regulations.

 

Media Contacts:

Okayama Taiho Pharmaceutical Co., Ltd.

TEL : 0869-64-1111

Helsinn Group

Paola Bonvicini

Group Head of Communication

Lugano, Switzerland

Tel: +41 (0) 91 985 21 21

Info-hhc@helsinn.com

For more information, please visitwww.helsinn.com and follow us on TwitterLinkedIn and Vimeo.