PMDA drug package insert

カルベジロール錠1.25mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Apr 9, 2024

Key facts

Brand names カルベジロール錠1.25mg「サワイ」, カルベジロール錠2.5mg「サワイ」, カルベジロール錠10mg「サワイ」, カルベジロール錠20mg「サワイ」
Nonproprietary names カルベジロール
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category 慢性心不全治療剤(錠1.25mg); 慢性心不全治療剤/頻脈性心房細動治療剤(錠2.5mg); 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(錠10mg); 持続性 高血圧・狭心症治療剤/頻脈性心房細動治療剤(錠20mg)
Therapeutic category codes 872149
YJ codes 2149032F3032, 2149032F4039, 2149032F1099, 2149032F2095
Approval numbers 22600AMX00242000, 22600AMX00243000, 22300AMX00471000, 22300AMX00472000
Package insert edition 第2版
Package insert date Apr 9, 2024
PMDA document key 300119_2149032F1099_1
PMDA company code 300119

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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