PMDA drug package insert
ビロイ点滴静注用100mg
PMDA Prescription drug · アステラス製薬株式会社 · package insert Nov 19, 2025
Key facts
| Brand names | ビロイ点滴静注用100mg, ビロイ点滴静注用300mg |
|---|---|
| Nonproprietary names | ゾルベツキシマブ（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CLDN18.2モノクローナル抗体CLDN18.2：Claudin-18 splice variant 2（クローディン-18スプライスバリアント2） |
| Therapeutic category codes | 874291 |
| YJ codes | 4291471D1021, 4291471D2028 |
| Approval numbers | 30600AMX00130, 30700AMX00198 |
| Package insert edition | 第5版 |
| Package insert date | Nov 19, 2025 |
| PMDA document key | 800126_4291471D1021_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: