PMDA drug package insert
フィブロガミンP静注用
PMDA Prescription drug · CSLベーリング株式会社 · package insert Dec 1, 2023
Key facts
| Brand names | フィブロガミンP静注用 |
|---|---|
| Nonproprietary names | ヒト血漿由来乾燥血液凝固第ＸＩＩＩ因子 |
| Companies | 製造販売（輸入）／CSLベーリング株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 血漿分画製剤（乾燥濃縮人血液凝固第XIII因子製剤） |
| Therapeutic category codes | 876343 |
| YJ codes | 6343431D2020 |
| Approval numbers | 22100AMX00055 |
| Package insert edition | 第1版 |
| Package insert date | Dec 1, 2023 |
| PMDA document key | 100806_6343431D2020_1 |
| PMDA company code | 100806 |
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: