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Post-marketing Safety Measures

English-Translated Package Inserts

Listing of English-translated package inserts prepared by MAHs
Non-proprietary name note) Brand name/
English-translated package insert
MAH
Enteral nutrient (for oral/enteral supplementation)
Package insert information in Japanese
Enevo Liquid for Enteral Use
English-translated package insert
Abbott Japan LLC
Enteral nutrient (for oral/enteral supplementation)
Package insert information in Japanese
Ensure H
English-translated package insert
Abbott Japan LLC
Enteral nutrient (for oral/enteral supplementation)
Package insert information in Japanese
Ensure Liquid
English-translated package insert
Abbott Japan LLC
Gadoteridol
Package insert information in Japanese
ProHans injections
ProHans syringes
English-translated package insert
Bracco Japan Co., Ltd.
Iomeprol
Package insert information in Japanese
Iomeron injections
English-translated package insert
Bracco Japan Co., Ltd.
Iomeron syringes
English-translated package insert

Note) English-translated package insert is also available by clicking the link to "Package Insert (English) PDF ver." in the "Package insert information in Japanese" page.


Please note;
These English translations are prepared by the MAHs. The Japanese language package insert is the official document, and this translation is provided solely as a reference material. In the case of any discrepancy between the two versions, the original Japanese version prevails. The provider of this translation shall not be responsible for any damage that may be attributed to the use of the translation. These translations shall not be reproduced, reprinted or used for profit. Since these translations were prepared based on the Japanese text current at that time, the translation may not reflect the latest information due to continuous revision of package inserts.

For Regulatory Notice ”Instruction of Package Insert for Prescription Drug” and ”Points to Consider for the Instruction of Package Insert for Prescription Drug” translated by industry associations (PhRMA and EFPIA), please refer to the PhRMA’s website.