PMDA drug package insert

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PMDA Prescription drug · 杏林製薬株式会社 · package insert May 7, 2024

Key facts

Brand names ケタス点眼液0.01%
Nonproprietary names イブジラスト
Companies 製造販売元/杏林製薬株式会社, 発売元/千寿製薬株式会社, 販売/武田薬品工業株式会社
Product type Prescription drug
Therapeutic category アレルギー性結膜炎治療剤
Therapeutic category codes 871319
YJ codes 1319741Q1050
Approval numbers 21900AMX01746000
Package insert edition 第2版
Package insert date May 7, 2024
PMDA document key 231099_1319741Q1050_3
PMDA company code 231099

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None Safety communications
  • Yes PMDA review report published
  • No Risk management plan (RMP)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA approved drugs and package inserts (Japan)

Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date:

Browse all PMDA approved drugs and package inserts (Japan)