PMDA drug package insert

オロパタジン点眼液0.1%「わかもと」

PMDA Prescription drug · シー・エイチ・オー新薬株式会社 · package insert Feb 29, 2024

Key facts

Brand names オロパタジン点眼液0.1%「わかもと」
Nonproprietary names オロパタジン塩酸塩
Companies 製造販売元/シー・エイチ・オー新薬株式会社, 販売元/わかもと製薬株式会社
Product type Prescription drug
Therapeutic category 抗アレルギー点眼剤
Therapeutic category codes 871319
YJ codes 1319752Q1148
Approval numbers 30300AMX00394000
Package insert edition 第1版
Package insert date Feb 29, 2024
PMDA document key 340460_1319752Q1148_1
PMDA company code 340460

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)

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)