PMDA drug package insert
ネクスビアザイム点滴静注用100mg
PMDA Prescription drug · サノフィ株式会社 · package insert Dec 12, 2023
Key facts
| Brand names | ネクスビアザイム点滴静注用100mg |
|---|---|
| Nonproprietary names | アバルグルコシダーゼ アルファ（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 | 遺伝子組換えポンペ病治療剤 |
| Therapeutic category codes | 873959 |
| YJ codes | 3959425D1028 |
| Approval numbers | 30300AMX00451 |
| Package insert edition | 第2版 |
| Package insert date | Dec 12, 2023 |
| PMDA document key | 780069_3959425D1028_1 |
| PMDA company code | 780069 |
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: