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TMCNet:  DAIICHI SANKYO -Announcement on obtaining in Japan the marketing and manufacturing license for the 4-valent combination vaccine for the prevention of Pertussis, Diphtheria, Tetanus and Poliomyelitis (Polio) 'Squarekids subcutaneous injection syringe'

[July 08, 2014]

DAIICHI SANKYO -Announcement on obtaining in Japan the marketing and manufacturing license for the 4-valent combination vaccine for the prevention of Pertussis, Diphtheria, Tetanus and Poliomyelitis (Polio) 'Squarekids subcutaneous injection syringe'

(ENP Newswire Via Acquire Media NewsEdge) ENP Newswire - 08 July 2014 Release date- 04072014 - Tokyo, Japan - Daiichi Sankyo Co., Ltd. (hereinafter Daiichi Sankyo) and Sanofi K.K. announce that Kitasato Daiichi Sankyo Vaccine Co., Ltd. (hereinafter Kitasato Daiichi Sankyo Vaccine), a Daiichi Sankyo Group company in Japan, has obtained a manufacturing and marketing licensing in Japan for the 4-valent combination vaccine for the prevention of Pertussis, Diphtheria, Tetanus and Poliomyelitis (Polio) (hereinafter 'this vaccine').

This vaccine is a product made of precipitated and purified pertussis, diphtheria, tetanus (DPT vaccine) of Kitasato Daiichi Sankyo and inactivated polio vaccine (Salk vaccine) (eIPV:Enhanced Inactivated Poliomyelitis Vaccine) of Sanofi Pasteur in a prefilled syringe, and is the first 4-valent combination vaccine in Japan that contains inactivated polio vaccine (Salk vaccine).

Daiichi Sankyo Group and Sanofi Pasteur are committed to contributing towards protecting the health of people in Japan by introducing innovative vaccines with high medical needs and by promoting the importance of preventative medicine in Japan.

Product Overview Commercial Name Squarekids subcutaneous injection syringe Generic Name Precipitated and purified pertussis-diphtheria-tetanus-inactivated polio vaccine (Salk vaccine) vaccine Regulatory category applicable to this drug Biological product, drastic medicine, prescription drug (Note - to be used under physician's prescription Specification-Content This drug contains in its 0.5ml, the equivalency of 4 units and over of protective antigen of Bordetella pertussis, 23.5 units and over of diphtheria toxoid, 13.5 units and over of tetanus toxoid, 40 D-antigen units 8 D-antigen units and 32 D-antigen units of inactivated polio virus type I, type II and type III respectively.

Effect-Efficacy Prevention of pertussis, diphtheria, tetanus and poliomyelitis Dosage-Administration Primary immunization: Normally, 3-dose administration to children by subcutaneous injection, each dose containing 0.5ml, with an interval of 3 weeks or longer.

Booster immunization: Normally, one dose of 0.5ml administration to children by subcutaneous injection, with an interval of 6 months or longer.

Approval date of manufacturing and marketing license July 4, 2014 Manufacturing and marketing license holder Kitasato Daiichi Sankyo Vaccine Co., Ltd.

Distributor Daiichi Sankyo Co., Ltd.

Marketing alliance parties Sanofi K.K.

Japan Vaccine Co., Ltd.

(c) 2014 Electronic News Publishing -

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