PMDA drug package insert
メプセヴィ点滴静注液10mg
PMDA Prescription drug · Ultragenyx Japan株式会社 · package insert Aug 22, 2022
Key facts
| Brand names | メプセヴィ点滴静注液10mg |
|---|---|
| Nonproprietary names | ベストロニダーゼ アルファ（遺伝子組換え） |
| Companies | 製造販売元／Ultragenyx Japan株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ムコ多糖症VII型治療剤 |
| Therapeutic category codes | 873959 |
| YJ codes | 3959427A1020 |
| Approval numbers | 30400AMX00001000 |
| Package insert edition | 第3版 |
| Package insert date | Aug 22, 2022 |
| PMDA document key | 166617_3959427A1020_2 |
| PMDA company code | 166617 |
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: