PMDA drug package insert
バイクロット配合静注用2.5mL（室温保存品）
PMDA Prescription drug · KMバイオロジクス株式会社 · package insert Mar 23, 2026
Key facts
| Brand names | バイクロット配合静注用2.5mL（室温保存品）, バイクロット配合静注用5mL（室温保存品）, バイクロット配合静注用10mL（室温保存品） |
|---|---|
| Nonproprietary names | 乾燥濃縮人血液凝固第Ｘ因子加活性化第ＶＩＩ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 | 6343500D1035, 6343500D2023, 6343500D3020 |
| Approval numbers | 30600AMX00168, 30600AMX00166, 30600AMX00167 |
| Package insert edition | 第3版 |
| Package insert date | Mar 23, 2026 |
| PMDA document key | 261976_6343500D2023_1 |
| PMDA company code | 261976 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: