PMDA drug package insert

ブロチゾラム錠0.25mg「アメル」

PMDA Prescription drug · 共和薬品工業株式会社 · package insert May 23, 2025

Key facts

Brand names ブロチゾラム錠0.25mg「アメル」
Nonproprietary names ブロチゾラム
Companies 製造販売元/共和薬品工業株式会社
Product type Prescription drug
Therapeutic category 睡眠導入剤
Therapeutic category codes 871124
YJ codes 1124009F1339
Approval numbers 22500AMX00380
Package insert edition 第2版
Package insert date May 23, 2025
PMDA document key 672173_1124009F1339_2
PMDA company code 672173

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)