PMDA drug package insert
ノボセブンHI静注用1mg シリンジ
PMDA Prescription drug · ノボ ノルディスク ファーマ株式会社 · package insert Apr 10, 2026
Key facts
| Brand names | ノボセブンHI静注用1mg シリンジ, ノボセブンHI静注用2mg シリンジ, ノボセブンHI静注用5mg シリンジ |
|---|---|
| Nonproprietary names | エプタコグ アルファ（活性型）（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 | 遺伝子組換え活性型血液凝固第Ⅶ因子製剤 |
| Therapeutic category codes | 876343 |
| YJ codes | 6343434D6020, 6343434D7026, 6343434D8022 |
| Approval numbers | 22600AMX00908000, 22600AMX00909000, 22600AMX00910000 |
| Package insert edition | 第3版 |
| Package insert date | Apr 10, 2026 |
| PMDA document key | 620023_6343434D6020_1 |
| PMDA company code | 620023 |
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: