PMDA drug package insert
イムブルビカカプセル140mg
PMDA Prescription drug · ヤンセンファーマ株式会社 · package insert Sep 28, 2026
Key facts
| Brand names | イムブルビカカプセル140mg |
|---|---|
| Nonproprietary names | イブルチニブ |
| Companies | 製造販売元（輸入）／ヤンセンファーマ株式会社, 共同開発／Pharmacyclics LLC |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤（ブルトン型チロシンキナーゼ阻害剤） |
| Therapeutic category codes | 874291 |
| YJ codes | 4291043M1027 |
| Approval numbers | 22800AMX00387000 |
| Package insert edition | 第11版 |
| Package insert date | Sep 28, 2026 |
| PMDA document key | 800155_4291043M1027_1 |
| PMDA company code | 800155 |
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: