PMDA drug package insert
オルツビーオ静注用250
PMDA Prescription drug · サノフィ株式会社 · package insert Feb 10, 2026
Key facts
| Brand names | オルツビーオ静注用250, オルツビーオ静注用500, オルツビーオ静注用1000, オルツビーオ静注用2000, オルツビーオ静注用3000, オルツビーオ静注用4000 |
|---|---|
| Nonproprietary names | エフアネソクトコグ 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 | von Willebrand因子非依存型 遺伝子組換え血液凝固第VIII因子製剤 |
| Therapeutic category codes | 876349 |
| YJ codes | 6343459D1028, 6343459D2024, 6343459D3020, 6343459D4027, 6343459D5023, 6343459D6020 |
| Approval numbers | 30500AMX00262000, 30500AMX00263000, 30500AMX00264000, 30500AMX00265000, 30500AMX00266000, 30500AMX00267000 |
| Package insert edition | 第11版 |
| Package insert date | Feb 10, 2026 |
| PMDA document key | 780069_6343459D1028_1 |
| PMDA company code | 780069 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: