PMDA drug package insert
パドセブ点滴静注用20㎎
PMDA Prescription drug · アステラス製薬株式会社 · package insert Feb 2, 2026
Key facts
| Brand names | パドセブ点滴静注用20㎎, パドセブ点滴静注用30㎎ |
|---|---|
| Nonproprietary names | エンホルツマブ ベドチン（遺伝子組換え） |
| Companies | 製造販売／アステラス製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤／抗Nectin-4抗体微小管阻害薬複合体 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291459D2027, 4291459D1020 |
| Approval numbers | 30500AMX00019, 30300AMX00454 |
| Package insert edition | 第10版 |
| Package insert date | Feb 2, 2026 |
| PMDA document key | 800126_4291459D1020_1 |
| PMDA company code | 800126 |
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: