PMDA drug package insert
ユニツキシン点滴静注17.5mg/5mL
PMDA Prescription drug · 大原薬品工業株式会社 · package insert Sep 22, 2021
Key facts
| Brand names | ユニツキシン点滴静注17.5mg/5mL |
|---|---|
| Nonproprietary names | ジヌツキシマブ（遺伝子組換え） |
| Companies | 製造販売元／大原薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤 抗GD2モノクローナル抗体 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291457A1025 |
| Approval numbers | 30300AMX00291000 |
| Package insert edition | 第1版 |
| Package insert date | Sep 22, 2021 |
| PMDA document key | 180095_4291457A1025_1 |
| PMDA company code | 180095 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: