PMDA drug package insert
イスツリサ錠1mg
PMDA Prescription drug · レコルダティ・レア・ディジーズ・ジャパン株式会社 · package insert Sep 16, 2025
Key facts
| Brand names | イスツリサ錠1mg, イスツリサ錠5mg |
|---|---|
| Nonproprietary names | オシロドロスタットリン酸塩 |
| Companies | 製造販売元／レコルダティ・レア・ディジーズ・ジャパン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 副腎皮質ホルモン合成阻害剤 |
| Therapeutic category codes | 872499 |
| YJ codes | 2499015F1026, 2499015F2022 |
| Approval numbers | 30300AMX00248000, 30300AMX00249000 |
| Package insert edition | 第5版 |
| Package insert date | Sep 16, 2025 |
| PMDA document key | 870276_2499015F1026_1 |
| PMDA company code | 870276 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: