PMDA drug package insert
オルミエント錠4mg
PMDA Prescription drug · 日本イーライリリー株式会社 · package insert Jul 13, 2026
Key facts
| Brand names | オルミエント錠4mg, オルミエント錠2mg, オルミエント錠1mg, オルミエント内用懸濁液2mg/mL |
|---|---|
| Nonproprietary names | バリシチニブ |
| Companies | 製造販売元／日本イーライリリー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヤヌスキナーゼ（JAK）阻害剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999043F2026, 3999043F1020, 3999043F3022, 3999043S1028 |
| Approval numbers | 22900AMX00582, 22900AMX00583, 30600AMX00135, 30800AMX00100 |
| Package insert edition | 第13版 |
| Package insert date | Jul 13, 2026 |
| PMDA document key | 530471_3999043F1020_1 |
| PMDA company code | 530471 |
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: