PMDA drug package insert
ジャイパーカ錠50mg
PMDA Prescription drug · 日本イーライリリー株式会社 · package insert Dec 8, 2025
Key facts
| Brand names | ジャイパーカ錠50mg, ジャイパーカ錠100mg |
|---|---|
| Nonproprietary names | ピルトブルチニブ |
| Companies | 製造販売元／日本イーライリリー株式会社, 販売元／日本新薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤 可逆的非共有結合型BTK注2）阻害剤; 注2）BTK:Bruton's Tyrosine Kinase（ブルトン型チロシンキナーゼ） |
| Therapeutic category codes | 874291 |
| YJ codes | 4291084F1027, 4291084F2023 |
| Approval numbers | 30600AMX00143, 30600AMX00144 |
| Package insert edition | 第4版 |
| Package insert date | Dec 8, 2025 |
| PMDA document key | 530471_4291084F1027_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: