PMDA drug package insert

アルプラゾラム錠0.4mg「アメル」

PMDA Prescription drug · 共和薬品工業株式会社 · package insert Jun 27, 2024

Key facts

Brand names アルプラゾラム錠0.4mg「アメル」, アルプラゾラム錠0.8mg「アメル」
Nonproprietary names アルプラゾラム
Companies 製造販売元/共和薬品工業株式会社
Product type Prescription drug
Therapeutic category マイナートランキライザー
Therapeutic category codes 871124
YJ codes 1124023F1126, 1124023F2084
Approval numbers 22700AMX00039, 22700AMX00085
Package insert edition 第2版
Package insert date Jun 27, 2024
PMDA document key 672173_1124023F1126_3
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)