PMDA drug package insert
プラバスタチンNa錠5mg「TCK」
PMDA Prescription drug · 辰巳化学株式会社 · package insert Aug 21, 2025
Key facts
| Brand names | プラバスタチンNa錠5mg「TCK」, プラバスタチンNa錠10mg「TCK」 |
|---|---|
| Nonproprietary names | プラバスタチンナトリウム |
| Companies | 製造販売元／辰巳化学株式会社 |
| Product type | Prescription drug |
| Therapeutic category | HMG-CoA還元酵素阻害剤; 高脂血症治療剤 |
| Therapeutic category codes | 872189 |
| YJ codes | 2189010F1403, 2189010F2426 |
| Approval numbers | 22500AMX00953000, 22500AMX00954000 |
| Package insert edition | 第2版 |
| Package insert date | Aug 21, 2025 |
| PMDA document key | 400278_2189010F1403_1 |
| 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: