PMDA drug package insert
ハイキュービア10%皮下注セット5g/50mL
PMDA Prescription drug · 武田薬品工業株式会社 · package insert Jun 1, 2026
Key facts
| Brand names | ハイキュービア10%皮下注セット5g/50mL, ハイキュービア10%皮下注セット10g/100mL, ハイキュービア10%皮下注セット20g/200mL |
|---|---|
| Nonproprietary names | ｐＨ４処理酸性人免疫グロブリン（皮下注射）・ボルヒアルロニダーゼ アルファ（遺伝子組換え） |
| Companies | 製造販売（輸入）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; ボルヒアルロニダーゼ アルファ（遺伝子組換え）製剤 |
| Therapeutic category codes | 876343 |
| YJ codes | 6343501A1025, 6343501A2021, 6343501A3028 |
| Approval numbers | 30600AMX00299, 30600AMX00300, 30600AMX00301 |
| Package insert edition | 第4版 |
| Package insert date | Jun 1, 2026 |
| PMDA document key | 400256_6343501A1025_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: