PMDA drug package insert

エサンブトール錠125mg

PMDA Prescription drug · サンド株式会社 · package insert Sep 1, 2025

Key facts

Brand names エサンブトール錠125mg, エサンブトール錠250mg
Nonproprietary names エタンブトール塩酸塩
Companies 製造販売/サンド株式会社
Product type Prescription drug
Therapeutic category エタンブトール製剤
Therapeutic category codes 876225
YJ codes 6225001F1044, 6225001F2040
Approval numbers 21600AMY00071000, 21600AMY00072000
Package insert edition 第1版
Package insert date Sep 1, 2025
PMDA document key 270428_6225001F1044_2
PMDA company code 270428

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 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)