PMDA drug package insert
ミンジュビ点滴静注用200mg
PMDA Prescription drug · インサイト・バイオサイエンシズ・ジャパン合同会社 · package insert Jul 27, 2026
Key facts
| Brand names | ミンジュビ点滴静注用200mg |
|---|---|
| Nonproprietary names | タファシタマブ（遺伝子組換え） |
| Companies | 製造販売元／インサイト・バイオサイエンシズ・ジャパン合同会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤/抗CD19モノクローナル抗体 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291485D1023 |
| Approval numbers | 30700AMX00263000 |
| Package insert edition | 第4版 |
| Package insert date | Jul 27, 2026 |
| PMDA document key | 150892_4291485D1023_1 |
| PMDA company code | 150892 |
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: