PMDA drug package insert

ロサルタンカリウム錠25mg「アメル」

PMDA Prescription drug · 共和薬品工業株式会社 · package insert Sep 9, 2025

Key facts

Brand names ロサルタンカリウム錠25mg「アメル」, ロサルタンカリウム錠50mg「アメル」, ロサルタンカリウム錠100mg「アメル」
Nonproprietary names ロサルタンカリウム
Companies 製造販売元/共和薬品工業株式会社
Product type Prescription drug
Therapeutic category A-IIアンタゴニスト
Therapeutic category codes 872149
YJ codes 2149039F1244, 2149039F2240, 2149039F3239
Approval numbers 22400AMX00399, 22400AMX00400, 22400AMX00401
Package insert edition 第3版
Package insert date Sep 9, 2025
PMDA document key 672173_2149039F1244_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)