PMDA drug package insert
ヒュンタラーゼ脳室内注射液 15 mg
PMDA Prescription drug · クリニジェン株式会社 · package insert Jul 1, 2025
Key facts
| Brand names | ヒュンタラーゼ脳室内注射液 15 mg |
|---|---|
| Nonproprietary names | イデュルスルファーゼ ベータ（遺伝子組換え） |
| Companies | 製造販売元／クリニジェン株式会社, 製造元／GC Biopharma Corp. |
| Product type | Prescription drug |
| Therapeutic category | ムコ多糖症II型治療剤 |
| Therapeutic category codes | 873959 |
| YJ codes | 3959423A1022 |
| Approval numbers | 30300AMX00030000 |
| Package insert edition | 第4版 |
| Package insert date | Jul 1, 2025 |
| PMDA document key | 850372_3959423A1022_1 |
| PMDA company code | 850372 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: