PMDA drug package insert
ウステキヌマブBS皮下注45mgシリンジ「F」
PMDA Prescription drug · 富士製薬工業株式会社 · package insert Aug 10, 2026
Key facts
| Brand names | ウステキヌマブBS皮下注45mgシリンジ「F」, ウステキヌマブBS皮下注90mgシリンジ「F」 |
|---|---|
| Nonproprietary names | ウステキヌマブ（遺伝子組換え） |
| Companies | 製造販売元（輸入）／富士製薬工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト型抗ヒトIL-12/23p40モノクローナル抗体製剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999473G1029, 3999473G2025 |
| Approval numbers | 30500AMX00238, 30800AMX00001 |
| Package insert edition | 第8版 |
| Package insert date | Aug 10, 2026 |
| PMDA document key | 670109_3999473G1029_1 |
| PMDA company code | 670109 |
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: