PMDA drug package insert

エナラプリルマレイン酸塩錠2.5mg「フソー」

PMDA Prescription drug · ダイト株式会社 · package insert Oct 1, 2026

Key facts

Brand names エナラプリルマレイン酸塩錠2.5mg「フソー」, エナラプリルマレイン酸塩錠5mg「フソー」, エナラプリルマレイン酸塩錠10mg「フソー」
Nonproprietary names エナラプリルマレイン酸塩
Companies 製造販売元/ダイト株式会社, 販売元/扶桑薬品工業株式会社
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 2144002F1350, 2144002F2403, 2144002F3329
Approval numbers 22800AMX00446, 22800AMX00445, 22800AMX00447
Package insert edition 第4版
Package insert date Oct 1, 2026
PMDA document key 400073_2144002F1350_1
PMDA company code 400073

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)