PMDA drug package insert
カルベジロール錠1.25mg「TCK」
PMDA Prescription drug · 辰巳化学株式会社 · package insert Oct 17, 2025
Key facts
| Brand names | カルベジロール錠1.25mg「TCK」, カルベジロール錠2.5mg「TCK」, カルベジロール錠10mg「TCK」 |
|---|---|
| Nonproprietary names | カルベジロール |
| Companies | 製造販売元／辰巳化学株式会社, 販売元／ヴィアトリス製薬合同会社 |
| 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） |
| Therapeutic category codes | 872149 |
| YJ codes | 2149032F3059, 2149032F4055, 2149032F1145 |
| Approval numbers | 22800AMX00314000, 22800AMX00315000, 22700AMX00299000 |
| Package insert edition | 第3版 |
| Package insert date | Oct 17, 2025 |
| PMDA document key | 400278_2149032F1145_5 |
| PMDA company code | 400278 |
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: