PMDA drug package insert

ミケラン点眼液1%

PMDA Prescription drug · 大塚製薬株式会社 · package insert Jul 5, 2021

Key facts

Brand names ミケラン点眼液1%, ミケラン点眼液2%
Nonproprietary names カルテオロール塩酸塩
Companies 製造販売元/大塚製薬株式会社, 提携/千寿製薬株式会社
Product type Prescription drug
Therapeutic category 緑内障・高眼圧症治療剤
Therapeutic category codes 871319
YJ codes 1319701Q1021, 1319701Q2028
Approval numbers 15900AMZ00195, 15900AMZ00196
Package insert edition 第1版
Package insert date Jul 5, 2021
PMDA document key 180078_1319701Q1021_1
PMDA company code 180078

At a glance

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

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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)