PMDA drug package insert
カルベジロール錠1.25mg「アメル」
PMDA Prescription drug · 共和薬品工業株式会社 · package insert Apr 9, 2024
Key facts
| Brand names | カルベジロール錠1.25mg「アメル」, カルベジロール錠2.5mg「アメル」, カルベジロール錠10mg「アメル」, カルベジロール錠20mg「アメル」 |
|---|---|
| Nonproprietary names | カルベジロール |
| Companies | 製造販売元／共和薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | カルベジロール錠1.25mg「アメル」 慢性心不全治療剤; カルベジロール錠2.5mg「アメル」 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「アメル」 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「アメル」 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 | 2149032F3067, 2149032F4063, 2149032F1080, 2149032F2087 |
| Approval numbers | 22800AMX00312, 22800AMX00313, 22300AMX00347, 22300AMX00348 |
| Package insert edition | 第2版 |
| Package insert date | Apr 9, 2024 |
| PMDA document key | 672173_2149032F1080_3 |
| PMDA company code | 672173 |
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: