PMDA drug package insert
イスパロクト静注用500
PMDA Prescription drug · ノボ ノルディスク ファーマ株式会社 · package insert Mar 4, 2024
Key facts
| Brand names | イスパロクト静注用500, イスパロクト静注用1000, イスパロクト静注用1500, イスパロクト静注用2000, イスパロクト静注用3000 |
|---|---|
| Nonproprietary names | ツロクトコグ アルファ ペゴル（遺伝子組換え） |
| Companies | 製造販売元／ノボ ノルディスク ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ペグ化遺伝子組換え型血液凝固第VIII因子製剤 |
| Therapeutic category codes | 876349 |
| YJ codes | 6343454D1025, 6343454D2021, 6343454D3028, 6343454D4024, 6343454D5020 |
| Approval numbers | 30100AMX00229000, 30100AMX00230000, 30100AMX00231000, 30100AMX00232000, 30100AMX00233000 |
| Package insert edition | 第3版 |
| Package insert date | Mar 4, 2024 |
| PMDA document key | 620023_6343454D1025_1 |
| PMDA company code | 620023 |
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: