PMDA drug package insert
ナグラザイム点滴静注液5mg
PMDA Prescription drug · BioMarin Pharmaceutical Japan株式会社 · package insert Aug 1, 2025
Key facts
| Brand names | ナグラザイム点滴静注液5mg |
|---|---|
| Nonproprietary names | ガルスルファーゼ（遺伝子組換え） |
| Companies | 製造販売元／BioMarin Pharmaceutical Japan株式会社, 製造元／BioMarin Pharmaceutical Inc. 米国 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝子組換えムコ多糖症VI型治療剤 |
| Therapeutic category codes | 873959 |
| YJ codes | 3959414A1023 |
| Approval numbers | 22000AMX01523000 |
| Package insert edition | 第3版 |
| Package insert date | Aug 1, 2025 |
| PMDA document key | 641173_3959414A1023_7 |
| PMDA company code | 641173 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: