PMDA drug package insert
イロクテイト静注用250
PMDA Prescription drug · サノフィ株式会社 · package insert Sep 29, 2025
Key facts
| Brand names | イロクテイト静注用250, イロクテイト静注用500, イロクテイト静注用750, イロクテイト静注用1000, イロクテイト静注用1500, イロクテイト静注用2000, イロクテイト静注用3000, イロクテイト静注用4000 |
|---|---|
| Nonproprietary names | エフラロクトコグ 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 | 遺伝子組換え血液凝固第VIII因子Fc領域 融合タンパク質製剤 |
| Therapeutic category codes | 876349 |
| YJ codes | 6343442D1022, 6343442D2029, 6343442D3025, 6343442D4021, 6343442D5028, 6343442D6024, 6343442D7020, 6343442D8027 |
| Approval numbers | 22600AMX01398000, 22600AMX01399000, 22600AMX01400000, 22600AMX01401000, 22600AMX01402000, 22600AMX01403000, 22600AMX01404000, 23000AMX00841000 |
| Package insert edition | 第4版 |
| Package insert date | Sep 29, 2025 |
| PMDA document key | 780069_6343442D1022_3 |
| PMDA company code | 780069 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- No 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: