PMDA drug package insert
ジャカビ錠5mg
PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Feb 14, 2025
Key facts
| Brand names | ジャカビ錠5mg, ジャカビ錠10mg, ジャカビ内用液小児用0.5% |
|---|---|
| Nonproprietary names | ルキソリチニブリン酸塩 |
| Companies | 製造販売（輸入）／ノバルティスファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヤヌスキナーゼ（JAK）阻害剤 |
| Therapeutic category codes | 874291, 873999 |
| YJ codes | 4291034F1029, 4291034F2025, 4291034S1027 |
| Approval numbers | 22600AMX00759000, 22900AMX00507000, 30600AMX00238000 |
| Package insert edition | 第5版 |
| Package insert date | Feb 14, 2025 |
| PMDA document key | 300242_4291034F1029_1 |
| PMDA company code | 300242 |
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: