PMDA drug package insert
サイラムザ点滴静注液100mg
PMDA Prescription drug · 日本イーライリリー株式会社 · package insert Apr 30, 2025
Key facts
| Brand names | サイラムザ点滴静注液100mg, サイラムザ点滴静注液500mg |
|---|---|
| Nonproprietary names | ラムシルマブ（遺伝子組換え） |
| Companies | 製造販売元／日本イーライリリー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤 ヒト型抗VEGFR-2注2）モノクローナル抗体; 注2）VEGFR-2 : Vascular Endothelial Growth Factor Receptor-2（血管内皮増殖因子受容体2） |
| Therapeutic category codes | 874291 |
| YJ codes | 4291429A1023, 4291429A2020 |
| Approval numbers | 22700AMX00664, 22700AMX00665 |
| Package insert edition | 第5版 |
| Package insert date | Apr 30, 2025 |
| PMDA document key | 530471_4291429A1023_1 |
| PMDA company code | 530471 |
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: