PMDA drug package insert
ベネフィクス静注用500
PMDA Prescription drug · ファイザー株式会社 · package insert Sep 9, 2025
Key facts
| Brand names | ベネフィクス静注用500, ベネフィクス静注用1000, ベネフィクス静注用2000, ベネフィクス静注用3000 |
|---|---|
| Nonproprietary names | ノナコグアルファ（遺伝子組換え） |
| Companies | 製造販売元／ファイザー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝子組換え血液凝固第Ⅸ因子製剤 |
| Therapeutic category codes | 876343 |
| YJ codes | 6343438D1026, 6343438D2022, 6343438D3029, 6343438D4025 |
| Approval numbers | 22100AMX02270, 22100AMX02271, 22100AMX02272, 22500AMX01782 |
| Package insert edition | 第3版 |
| Package insert date | Sep 9, 2025 |
| PMDA document key | 672212_6343438D1026_3 |
| PMDA company code | 672212 |
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: