PMDA drug package insert
オペプリム
PMDA Prescription drug · 株式会社ヤクルト本社 · package insert Aug 25, 2026
Key facts
| Brand names | オペプリム |
|---|---|
| Nonproprietary names | ミトタン |
| Companies | 製造販売元／株式会社ヤクルト本社 |
| Product type | Prescription drug |
| Therapeutic category | 副腎癌化学療法剤; 副腎皮質ホルモン合成阻害剤 |
| Therapeutic category codes | 872499 |
| YJ codes | 2499006M1026 |
| Approval numbers | 15800AMY00091 |
| Package insert edition | 第6版 |
| Package insert date | Aug 25, 2026 |
| PMDA document key | 800015_2499006M1026_2 |
| PMDA company code | 800015 |
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: