PMDA drug package insert

エブトール125mg錠

PMDA Prescription drug · 科研製薬株式会社 · package insert Mar 23, 2023

Key facts

Brand names エブトール125mg錠, エブトール250mg錠
Nonproprietary names エタンブトール塩酸塩
Companies 製造販売元/科研製薬株式会社
Product type Prescription drug
Therapeutic category エタンブトール製剤
Therapeutic category codes 876225
YJ codes 6225001F1036, 6225001F2032
Approval numbers 14100AZZ05543, 14100AZZ06845
Package insert edition 第2版
Package insert date Mar 23, 2023
PMDA document key 200022_6225001F1036_1
PMDA company code 200022

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)