PMDA drug package insert
オテズラ錠10mg
PMDA Prescription drug · アムジェン株式会社 · package insert Sep 29, 2026
Key facts
| Brand names | オテズラ錠10mg, オテズラ錠20mg, オテズラ錠30mg |
|---|---|
| Nonproprietary names | アプレミラスト |
| Companies | 製造販売元／アムジェン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | PDE4阻害剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999042F1025, 3999042F2021, 3999042F3028 |
| Approval numbers | 22800AMX00729000, 22800AMX00730000, 22800AMX00731000 |
| Package insert edition | 第5版 |
| Package insert date | Sep 29, 2026 |
| PMDA document key | 112292_3999042F1025_3 |
| PMDA company code | 112292 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: