Pharmaceuticals and Medical Devices Agency This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. Pharmaceuticals and Medical Devices Agency 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan E-mail: [email protected]Summary of Investigation Results Antimicrobials with indications for otitis media (excluding antimicrobials contraindicated for pediatric use) September 8, 2020 Non-proprietary name See Attachment Branded name (Marketing authorization holder) See Attachment Indications See Attachment Summary of revisions 1.–9., 11.–15. (solution for topical use and oral dosage form), 16., 18.–46. (oral dosage form without dosage and administration for pediatric use), 47.–55., 57.–61. To the Precautions concerning Indications section or the PRECAUTIONS CONCERNING INDICATIONS section, a statement should be added that the Guidance for Appropriate Use of Antimicrobials should be consulted for the treatment of otitis media and this drug should be administered in cases where treatment with antimicrobials is determined to be appropriate. 10., 15 (preparations for otic use), 17., 46. (oral dosage form for pediatric use), 56., 62. A Precautions concerning Indications section or a PRECAUTIONS CONCERNING INDICATIONS section should be newly added to include a statement that the Guidance for
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Summary of Investigation Results · Tarivid Otic Solution 0.3%, and the others Alfresa Pharma Corporation, and the others Otitis externa, otitis media 11. Kanamycin sulfate Kanamycin
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Pharmaceuticals and Medical Devices Agency
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
This English version is intended to be a reference material for the convenience of users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail.
Pharmaceuticals and Medical Devices Agency
3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan