PMDA drug package insert
ビーリンサイト点滴静注用35μg
PMDA Prescription drug · アムジェン株式会社 · package insert May 11, 2026
Key facts
| Brand names | ビーリンサイト点滴静注用35μg |
|---|---|
| Nonproprietary names | ブリナツモマブ（遺伝子組換え） |
| Companies | 製造販売元／アムジェン株式会社, 販売元／アステラス製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤／二重特異性抗体製剤 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291445D1029 |
| Approval numbers | 23000AMX00811000 |
| Package insert edition | 第4版 |
| Package insert date | May 11, 2026 |
| PMDA document key | 112292_4291445D1029_2 |
| PMDA company code | 112292 |
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: