PMDA drug package insert
アービタックス注射液100mg
PMDA Prescription drug · メルクバイオファーマ株式会社 · package insert Dec 17, 2025
Key facts
| Brand names | アービタックス注射液100mg, アービタックス注射液500mg |
|---|---|
| Nonproprietary names | セツキシマブ（遺伝子組換え） |
| Companies | 製造販売元／メルクバイオファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤 抗ヒトEGFR モノクローナル抗体EGFR：Epidermal Growth Factor Receptor（上皮細胞増殖因子受容体） |
| Therapeutic category codes | 874291 |
| YJ codes | 4291415A1021, 4291415A2028 |
| Approval numbers | 22000AMX01771000, 30500AMX00233000 |
| Package insert edition | 第6版 |
| Package insert date | Dec 17, 2025 |
| PMDA document key | 380079_4291415A1021_1 |
| PMDA company code | 380079 |
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: