PMDA drug package insert
オルプロリクス静注用250
PMDA Prescription drug · サノフィ株式会社 · package insert Sep 27, 2023
Key facts
| Brand names | オルプロリクス静注用250, オルプロリクス静注用500, オルプロリクス静注用1000, オルプロリクス静注用2000, オルプロリクス静注用3000, オルプロリクス静注用4000 |
|---|---|
| Nonproprietary names | エフトレノナコグ 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IX因子 Fc領域融合タンパク質製剤 |
| Therapeutic category codes | 876349 |
| YJ codes | 6343441D5023, 6343441D1028, 6343441D2024, 6343441D3020, 6343441D4027, 6343441D6020 |
| Approval numbers | 22600AMX00753000, 22600AMX00754000, 22600AMX00755000, 22600AMX00756000, 22600AMX00757000, 23000AMX00440000 |
| Package insert edition | 第2版 |
| Package insert date | Sep 27, 2023 |
| PMDA document key | 780069_6343441D1028_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: