PMDA drug package insert

エナラプリルマレイン酸塩細粒1%「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 エナラプリルマレイン酸塩細粒1%「アメル」
Nonproprietary names エナラプリルマレイン酸塩
Companies 製造販売元/共和薬品工業株式会社
Product type Prescription drug
Therapeutic category 持続性アンジオテンシン変換酵素阻害剤
Therapeutic category codes 872144, 872179
YJ codes 2144002C1036
Approval numbers 30100AMX00362
Package insert edition 第2版
Package insert date Sep 9, 2025
PMDA document key 672173_2144002C1036_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)