PMDA drug package insert

カルベジロール錠1.25mg「ニプロ」

PMDA Prescription drug · ニプロ株式会社 · package insert Apr 1, 2025

Key facts

Brand names カルベジロール錠1.25mg「ニプロ」, カルベジロール錠2.5mg「ニプロ」, カルベジロール錠10mg「ニプロ」, カルベジロール錠20mg「ニプロ」
Nonproprietary names カルベジロール
Companies 製造販売元/ニプロ株式会社
Product type Prescription drug
Therapeutic category カルベジロール錠1.25mg「ニプロ」 慢性心不全治療剤; カルベジロール錠2.5mg「ニプロ」 慢性心不全治療剤、頻脈性心房細動治療剤; カルベジロール錠10mg「ニプロ」 持続性 高血圧・狭心症治療剤、慢性心不全治療剤、頻脈性心房細動治療剤; カルベジロール錠20mg「ニプロ」 持続性 高血圧・狭心症治療剤、頻脈性心房細動治療剤
Therapeutic category codes 872149
YJ codes 2149032F3156, 2149032F4152, 2149032F1200, 2149032F2206
Approval numbers 30400AMX00239, 30400AMX00241, 30400AMX00240, 30400AMX00242
Package insert edition 第1版
Package insert date Apr 1, 2025
PMDA document key 530100_2149032F1200_2
PMDA company code 530100

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None 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:

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