PMDA drug package insert

テモカプリル塩酸塩錠1mg「NP」

PMDA Prescription drug · ニプロ株式会社 · package insert Sep 9, 2025

Key facts

Brand names テモカプリル塩酸塩錠1mg「NP」, テモカプリル塩酸塩錠2mg「NP」, テモカプリル塩酸塩錠4mg「NP」
Nonproprietary names テモカプリル塩酸塩
Companies 製造販売元/ニプロ株式会社
Product type Prescription drug
Therapeutic category 胆汁・腎排泄型ACE阻害剤
Therapeutic category codes 872144
YJ codes 2144009F1050, 2144009F2057, 2144009F3053
Approval numbers 22100AMX00319, 22100AMX00229, 22100AMX00315
Package insert edition 第2版
Package insert date Sep 9, 2025
PMDA document key 530100_2144009F1050_4
PMDA company code 530100

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)