PMDA drug package insert
ロスーゼット配合錠LD
PMDA Prescription drug · オルガノン株式会社 · package insert Sep 29, 2026
Key facts
| Brand names | ロスーゼット配合錠LD, ロスーゼット配合錠HD |
|---|---|
| Nonproprietary names | エゼチミブ・ロスバスタチンカルシウム配合剤 |
| Companies | 製造販売元／オルガノン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 小腸コレステロールトランスポーター阻害剤／HMG-CoA還元酵素阻害剤配合剤 |
| Therapeutic category codes | 872189 |
| YJ codes | 2189102F1024, 2189102F2020 |
| Approval numbers | 23100AMX00300000, 23100AMX00301000 |
| Package insert edition | 第9版 |
| Package insert date | Sep 29, 2026 |
| PMDA document key | 181615_2189102F1024_3 |
| PMDA company code | 181615 |
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: