PMDA drug package insert
ポートラーザ点滴静注液800mg
PMDA Prescription drug · 日本化薬株式会社 · package insert Jun 7, 2023
Key facts
| Brand names | ポートラーザ点滴静注液800mg |
|---|---|
| Nonproprietary names | ネシツムマブ（遺伝子組換え） |
| Companies | 製造販売元／日本化薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤 ヒト型抗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 | 4291448A1026 |
| Approval numbers | 30100AMX00019 |
| Package insert edition | 第2版 |
| Package insert date | Jun 7, 2023 |
| PMDA document key | 530191_4291448A1026_1 |
| PMDA company code | 530191 |
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: