PMDA drug package insert
ロスバスタチン錠2.5mg「オーハラ」
PMDA Prescription drug · 大原薬品工業株式会社 · package insert May 19, 2026
Key facts
| Brand names | ロスバスタチン錠2.5mg「オーハラ」, ロスバスタチン錠5mg「オーハラ」, ロスバスタチンOD錠2.5mg「オーハラ」, ロスバスタチンOD錠5mg「オーハラ」 |
|---|---|
| Nonproprietary names | ロスバスタチンカルシウム |
| Companies | 製造販売元／大原薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | HMG-CoA還元酵素阻害剤 |
| Therapeutic category codes | 872189 |
| YJ codes | 2189017F1103, 2189017F2100, 2189017F3106, 2189017F4102 |
| Approval numbers | 22900AMX00803000, 22900AMX00804000, 22900AMX00809000, 22900AMX00810000 |
| Package insert edition | 第4版 |
| Package insert date | May 19, 2026 |
| PMDA document key | 180095_2189017F1103_1 |
| PMDA company code | 180095 |
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: