PMDA drug package insert
セレザイム静注用400単位
PMDA Prescription drug · サノフィ株式会社 · package insert Nov 26, 2025
Key facts
| Brand names | セレザイム静注用400単位 |
|---|---|
| Nonproprietary names | イミグルセラーゼ（遺伝子組換え） |
| Companies | 製造販売元／サノフィ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝子組換えゴーシェ病治療剤 |
| Therapeutic category codes | 873959 |
| YJ codes | 3959406D2021 |
| Approval numbers | 22300AMX00439 |
| Package insert edition | 第3版 |
| Package insert date | Nov 26, 2025 |
| PMDA document key | 780069_3959406D2021_2 |
| PMDA company code | 780069 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- No 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: