PMDA drug package insert

エチゾラム錠0.25mg「NP」

PMDA Prescription drug · ニプロ株式会社 · package insert Apr 24, 2025

Key facts

Brand names エチゾラム錠0.25mg「NP」, エチゾラム錠0.5mg「NP」, エチゾラム錠1mg「NP」
Nonproprietary names エチゾラム
Companies 製造販売元/ニプロ株式会社
Product type Prescription drug
Therapeutic category 精神安定剤
Therapeutic category codes 871179
YJ codes 1179025F3037, 1179025F1220, 1179025F2189
Approval numbers 22400AMX00201, 22300AMX00916, 22300AMX00917
Package insert edition 第1版
Package insert date Apr 24, 2025
PMDA document key 530100_1179025F1220_3
PMDA company code 530100

At a glance

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