PMDA drug package insert
ボルヒール組織接着用（0.5mL）
PMDA Prescription drug · KMバイオロジクス株式会社 · package insert Apr 1, 2025
Key facts
| Brand names | ボルヒール組織接着用（0.5mL）, ボルヒール組織接着用（1mL）, ボルヒール組織接着用（2mL）, ボルヒール組織接着用（3mL）, ボルヒール組織接着用（5mL） |
|---|---|
| Nonproprietary names | フィブリノゲン加第ＸＩＩＩ因子 |
| Companies | 製造販売元／KMバイオロジクス株式会社, 販売元／Meiji Seika ファルマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 血漿分画製剤（生体組織接着剤） |
| Therapeutic category codes | 876349 |
| YJ codes | 6349801X1026, 6349801X2022, 6349801X3029, 6349801X4025, 6349801X5021 |
| Approval numbers | 22100AMX01038 |
| Package insert edition | 第3版 |
| Package insert date | Apr 1, 2025 |
| PMDA document key | 261976_6349801X1026_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: