PMDA drug package insert

オノアクト点滴静注用50mg

PMDA Prescription drug · 小野薬品工業株式会社 · package insert Aug 3, 2026

Key facts

Brand names オノアクト点滴静注用50mg, オノアクト点滴静注用150mg
Nonproprietary names ランジオロール塩酸塩
Companies 製造販売/小野薬品工業株式会社
Product type Prescription drug
Therapeutic category 短時間作用型β1選択的遮断剤
Therapeutic category codes 872123
YJ codes 2123404D1033, 2123404D3028
Approval numbers 22600AMX00879000, 22700AMX00168000
Package insert edition 第4版
Package insert date Aug 3, 2026
PMDA document key 180188_2123404D1033_1
PMDA company code 180188

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes PMDA review report published
  • Yes 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)