PMDA drug package insert
ハイゼントラ20%皮下注1g/5mL
PMDA Prescription drug · CSLベーリング株式会社 · package insert Jul 31, 2026
Key facts
| Brand names | ハイゼントラ20%皮下注1g/5mL, ハイゼントラ20%皮下注2g/10mL, ハイゼントラ20%皮下注4g/20mL, ハイゼントラ20%皮下注1g/5mLシリンジ, ハイゼントラ20%皮下注2g/10mLシリンジ, ハイゼントラ20%皮下注4g/20mLシリンジ, ハイゼントラ20%皮下注10g/50mLシリンジ |
|---|---|
| Nonproprietary names | ｐＨ４処理酸性人免疫グロブリン（皮下注射） |
| 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（皮下注用人免疫グロブリン製剤） |
| Therapeutic category codes | 876343 |
| YJ codes | 6343439A1024, 6343439A2020, 6343439A3027, 6343439G1027, 6343439G2023, 6343439G3020, 6343439G4026 |
| Approval numbers | 22500AMX01830, 22500AMX01831, 22500AMX01832, 30600AMX00023, 30600AMX00024, 30600AMX00025, 30700AMX00247 |
| Package insert edition | 第5版 |
| Package insert date | Jul 31, 2026 |
| PMDA document key | 100806_6343439A1024_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
- 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: