PMDA drug package insert
イズカーゴ点滴静注用10mg
PMDA Prescription drug · JCRファーマ株式会社 · package insert Jul 17, 2024
Key facts
| Brand names | イズカーゴ点滴静注用10mg |
|---|---|
| Nonproprietary names | パビナフスプ アルファ(遺伝子組換え) |
| Companies | 製造販売元/JCRファーマ株式会社, プロモーション提携/住友ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝子組換えムコ多糖症Ⅱ型治療剤 |
| Therapeutic category codes | 873959 |
| YJ codes | 3959424D1023 |
| Approval numbers | 30300AMX00260000 |
| Package insert edition | 第3版 |
| Package insert date | Jul 17, 2024 |
| PMDA document key | 530210_3959424D1023_1 |
| PMDA company code | 530210 |
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: