PMDA drug package insert
アーチスト錠1.25mg
PMDA Prescription drug · 第一三共株式会社 · package insert Apr 9, 2024
Key facts
| Brand names | アーチスト錠1.25mg, アーチスト錠2.5mg, アーチスト錠10mg, アーチスト錠20mg |
|---|---|
| Nonproprietary names | カルベジロール |
| Companies | 製造販売元／第一三共株式会社 |
| Product type | Prescription drug |
| Therapeutic category | アーチスト錠1.25mg 慢性心不全治療剤; アーチスト錠2.5mg 慢性心不全治療剤、頻脈性心房細動治療剤; アーチスト錠10mg 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; アーチスト錠20mg 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 | 2149032F3024, 2149032F4020, 2149032F1021, 2149032F2028 |
| Approval numbers | 21400AMZ00625, 21400AMZ00626, 20500AMZ00009, 20500AMZ00010 |
| Package insert edition | 第2版 |
| Package insert date | Apr 9, 2024 |
| PMDA document key | 430574_2149032F1021_2 |
| PMDA company code | 430574 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None 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: