PMDA drug package insert
ノバクトM静注用500単位
PMDA Prescription drug · KMバイオロジクス株式会社 · package insert Sep 16, 2025
Key facts
| Brand names | ノバクトM静注用500単位, ノバクトM静注用1000単位, ノバクトM静注用2000単位 |
|---|---|
| Nonproprietary names | 乾燥濃縮人血液凝固第ＩＸ因子 |
| Companies | 製造販売元／KMバイオロジクス株式会社, プロモーション提携／一般社団法人日本血液製剤機構 |
| Product type | Prescription drug |
| Therapeutic category | 血漿分画製剤 |
| Therapeutic category codes | 876343 |
| YJ codes | 6343429D7041, 6343429D8064, 6343429L2028 |
| Approval numbers | 22700AMX00170, 22700AMX00171, 22700AMX00172 |
| Package insert edition | 第5版 |
| Package insert date | Sep 16, 2025 |
| PMDA document key | 261976_6343429D7041_3 |
| PMDA company code | 261976 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- No 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: