PMDA drug package insert
ローコール錠10mg
PMDA Prescription drug · サンファーマ株式会社 · package insert Jul 16, 2024
Key facts
| Brand names | ローコール錠10mg, ローコール錠20mg, ローコール錠30mg |
|---|---|
| Nonproprietary names | フルバスタチンナトリウム |
| Companies | 製造販売元／サンファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | HMG-CoA還元酵素阻害剤 |
| Therapeutic category codes | 872189 |
| YJ codes | 2189012F1020, 2189012F2026, 2189012F3022 |
| Approval numbers | 21500AMZ00035000, 21500AMZ00036000, 21500AMZ00037000 |
| Package insert edition | 第2版 |
| Package insert date | Jul 16, 2024 |
| PMDA document key | 480866_2189012F1020_5 |
| PMDA company code | 480866 |
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: