PMDA drug package insert
スプリセル錠20mg
PMDA Prescription drug · ブリストル・マイヤーズ スクイブ株式会社 · package insert Oct 22, 2025
Key facts
| Brand names | スプリセル錠20mg, スプリセル錠50mg |
|---|---|
| Nonproprietary names | ダサチニブ水和物 |
| Companies | 製造販売元／ブリストル・マイヤーズ スクイブ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤; チロシンキナーゼインヒビター |
| Therapeutic category codes | 874291 |
| YJ codes | 4291020F1027, 4291020F2023 |
| Approval numbers | 22100AMX00395000, 22100AMX00396000 |
| Package insert edition | 第3版 |
| Package insert date | Oct 22, 2025 |
| PMDA document key | 670605_4291020F1027_1 |
| PMDA company code | 670605 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes 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: