PMDA drug package insert
エイフスチラ静注用250
PMDA Prescription drug · CSLベーリング株式会社 · package insert Mar 1, 2024
Key facts
| Brand names | エイフスチラ静注用250, エイフスチラ静注用500, エイフスチラ静注用1000, エイフスチラ静注用1500, エイフスチラ静注用2000, エイフスチラ静注用2500, エイフスチラ静注用3000 |
|---|---|
| Nonproprietary names | ロノクトコグ アルファ（遺伝子組換え） |
| Companies | 製造販売（輸入）／CSLベーリング株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝子組換え単鎖血液凝固第VIII因子製剤 |
| Therapeutic category codes | 876349 |
| YJ codes | 6343450D1027, 6343450D2023, 6343450D3020, 6343450D4026, 6343450D5022, 6343450D6029, 6343450D7025 |
| Approval numbers | 22900AMX00975, 22900AMX00976, 22900AMX00977, 22900AMX00978, 22900AMX00979, 22900AMX00980, 22900AMX00981 |
| Package insert edition | 第1版 |
| Package insert date | Mar 1, 2024 |
| PMDA document key | 100806_6343450D1027_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: