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November 26, 2015
| Japan Tobacco Inc. |
| Torii Pharmaceutical Co., Ltd. |
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Launch of “Allergen Scratch Extract Positive control (Torii) Histamine Dihydrochloride”
in Japan |
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Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551) announced that Torii would launch “Allergen Scratch Extract Positive control (Torii) Histamine Dihydrochloride” in Japan on January 18, 2016, following the National Health Insurance price listing as of today. JT received manufacturing and marketing approval of this medical product from the Japanese Ministry of Health, Labour and Welfare on September 28, 2015.
The product is used as a positive control in skin tests to identify allergens that cause allergic reactions.
Histamine dihydrochloride solution used to be prepared from reagent by healthcare practitioners in Japan, as no positive control for allergy skin tests existed as a medical product. Solving the complicated preparation method and the instability of the solution have been concerns in daily medical practice. In this circumstance, a histamine dihydrochloride was publicly offered for a development company by the Evaluation Committee on Unapproved or Off-labeled Drugs with High Medical Needs*1. JT and Torii acquired exclusive rights to develop and commercialize the histamine dihydrochloride preparation in Japan from ALK-Abelló A/S in 2013, and jointly developed this medical product with a grant funding from the Pharmaceutical Development Support Center.
JT and Torii expect to contribute to treating allergies, through marketing “Allergen Scratch Extract Positive control (Torii) Histamine Dihydrochloride” in Japan.
*1 A committee set up by the Ministry of Health, Labour and Welfare, to facilitate development of unapproved and off-label drugs which have been available outside Japan.
| Product outline |
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Product Name: |
Allergen Scratch Extract Positive control (Torii) Histamine Dihydrochloride |
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Generic Name: |
Histamine Dihydrochloride |
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Indications: |
Diagnosis
Positive control of skin tests for allergens |
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Dosage and Administration: |
Diagnosis
Usually, the product is used as a positive control for allergen screening. The superficial layer of the skin is pierced in such a way as to avoid bleeding by scarification (prick method) or incision (scratch method), and one drop of the product is applied onto the site of skin. |
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Package: |
2mL bottle (with a dropper cap) |
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NHI Drug Price: |
¥ 7,966 per bottle |
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Approval Date: |
September 28, 2015 |
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NHI Pricing Date: |
November 26, 2015 |
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Launch Date: |
January 18, 2016 |
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Manufacturing and Distributor: |
Japan Tobacco Inc. |
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Distributor: |
Torii Pharmaceutical Co., Ltd. |
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