PMDA drug package insert
ケイセントラ静注用500
PMDA Prescription drug · CSLベーリング株式会社 · package insert May 12, 2025
Key facts
| Brand names | ケイセントラ静注用500, ケイセントラ静注用1000 |
|---|---|
| Nonproprietary names | 乾燥濃縮人プロトロンビン複合体 |
| 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（静注用人プロトロンビン複合体製剤） |
| Therapeutic category codes | 876343 |
| YJ codes | 6343449D1024, 6343449D2020 |
| Approval numbers | 22900AMX00536, 22900AMX00537 |
| Package insert edition | 第3版 |
| Package insert date | May 12, 2025 |
| PMDA document key | 100806_6343449D1024_1 |
| PMDA company code | 100806 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: