PMDA drug package insert
ヌーイック静注用250
PMDA Prescription drug · 藤本製薬株式会社 · package insert Jul 24, 2024
Key facts
| Brand names | ヌーイック静注用250, ヌーイック静注用500, ヌーイック静注用1000, ヌーイック静注用2000, ヌーイック静注用2500, ヌーイック静注用3000, ヌーイック静注用4000 |
|---|---|
| Nonproprietary names | シモクトコグ アルファ（遺伝子組換え） |
| Companies | 製造販売元／藤本製薬株式会社, 提携先／Octapharma AG（スイス） |
| Product type | Prescription drug |
| Therapeutic category | 遺伝子組換え型血液凝固第Ⅷ因子製剤 |
| Therapeutic category codes | 876349 |
| YJ codes | 6343457D1029, 6343457D2025, 6343457D3021, 6343457D4028, 6343457D5024, 6343457D6020, 6343457D7027 |
| Approval numbers | 30300AMX00012000, 30300AMX00006000, 30300AMX00007000, 30300AMX00008000, 30300AMX00009000, 30300AMX00010000, 30300AMX00011000 |
| Package insert edition | 第4版 |
| Package insert date | Jul 24, 2024 |
| PMDA document key | 670142_6343457D1029_1 |
| PMDA company code | 670142 |
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: