PMDA drug package insert

エチゾラム錠0.25mg「ツルハラ」

PMDA Prescription drug · 鶴原製薬株式会社 · package insert Jan 10, 2024

Key facts

Brand names エチゾラム錠0.25mg「ツルハラ」, エチゾラム錠0.5mg「ツルハラ」, エチゾラム錠1mg「ツルハラ」
Nonproprietary names エチゾラム
Companies 製造販売元/鶴原製薬株式会社
Product type Prescription drug
Therapeutic category 精神安定剤
Therapeutic category codes 871179
YJ codes 1179025F3088, 1179025F1298, 1179025F2251
Approval numbers 22600AMX01249000, 22500AMX00742000, 22500AMX00743000
Package insert edition 第1版
Package insert date Jan 10, 2024
PMDA document key 460028_1179025F1298_1
PMDA company code 460028

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)