PMDA drug package insert

レニベース錠2.5

PMDA Prescription drug · オルガノン株式会社 · package insert Sep 9, 2025

Key facts

Brand names レニベース錠2.5, レニベース錠5, レニベース錠10
Nonproprietary names エナラプリルマレイン酸塩
Companies 製造販売元/オルガノン株式会社
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 2144002F1024, 2144002F2020, 2144002F3027
Approval numbers 16100AMZ03244000, 16100AMZ03245000, 16100AMZ03246000
Package insert edition 第5版
Package insert date Sep 9, 2025
PMDA document key 181615_2144002F1024_3
PMDA company code 181615

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 Safety communications
  • Yes 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)