PMDA drug package insert
イミフィンジ点滴静注120mg
PMDA Prescription drug · アストラゼネカ株式会社 · package insert Sep 29, 2026
Key facts
| Brand names | イミフィンジ点滴静注120mg, イミフィンジ点滴静注500mg |
|---|---|
| Nonproprietary names | デュルバルマブ（遺伝子組換え） |
| Companies | 製造販売元／アストラゼネカ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | －抗悪性腫瘍剤－ ヒト型抗ヒトPD-L1モノクローナル抗体 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291443A1023, 4291443A2020 |
| Approval numbers | 23000AMX00485, 23000AMX00486 |
| Package insert edition | 第15版 |
| Package insert date | Sep 29, 2026 |
| PMDA document key | 670227_4291443A1023_1 |
| PMDA company code | 670227 |
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: