PMDA drug package insert
ピリヴィジェン10%静注2.5g/25mL
PMDA Prescription drug · CSLベーリング株式会社 · package insert May 18, 2026
Key facts
| Brand names | ピリヴィジェン10%静注2.5g/25mL, ピリヴィジェン10%静注5g/50mL, ピリヴィジェン10%静注10g/100mL, ピリヴィジェン10%静注20g/200mL |
|---|---|
| Nonproprietary names | ｐＨ４処理酸性人免疫グロブリン |
| Companies | 製造販売（輸入）／CSLベーリング株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 血漿分画製剤（液状静注用人免疫グロブリン製剤） |
| Therapeutic category codes | 876343 |
| YJ codes | 6343427H1020, 6343427A7038, 6343427A8034, 6343427A9030 |
| Approval numbers | 30200AMX00452, 30200AMX00418, 30200AMX00419, 30200AMX00420 |
| Package insert edition | 第4版 |
| Package insert date | May 18, 2026 |
| PMDA document key | 100806_6343427H1020_1 |
| PMDA company code | 100806 |
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: