PMDA drug package insert
キュービトル20%皮下注2g/10mL
PMDA Prescription drug · 武田薬品工業株式会社 · package insert Mar 5, 2025
Key facts
| Brand names | キュービトル20%皮下注2g/10mL, キュービトル20%皮下注4g/20mL, キュービトル20%皮下注8g/40mL |
|---|---|
| Nonproprietary names | ｐＨ４処理酸性人免疫グロブリン（皮下注射） |
| Companies | 製造販売元／武田薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 血漿分画製剤; 皮下注用人免疫グロブリン製剤 |
| Therapeutic category codes | 876343 |
| YJ codes | 6343439A4023, 6343439A5020, 6343439A6026 |
| Approval numbers | 30500AMX00255, 30500AMX00256, 30500AMX00257 |
| Package insert edition | 第4版 |
| Package insert date | Mar 5, 2025 |
| PMDA document key | 400256_6343439A4023_1 |
| PMDA company code | 400256 |
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: