PMDA drug package insert
アダリムマブBS皮下注20mgシリンジ0.4mL「FKB」
PMDA Prescription drug · 協和キリン富士フイルムバイオロジクス株式会社 · package insert Mar 25, 2026
Key facts
| Brand names | アダリムマブBS皮下注20mgシリンジ0.4mL「FKB」, アダリムマブBS皮下注40mgシリンジ0.8mL「FKB」, アダリムマブBS皮下注40mgペン0.8mL「FKB」 |
|---|---|
| Nonproprietary names | アダリムマブ（遺伝子組換え） |
| Companies | 製造販売元／協和キリン富士フイルムバイオロジクス株式会社, 販売元／サンド株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト型抗ヒトTNFαモノクローナル抗体製剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999457G1020, 3999457G2026, 3999457G3022 |
| Approval numbers | 30200AMX00468000, 30200AMX00466000, 30200AMX00467000 |
| Package insert edition | 第12版 |
| Package insert date | Mar 25, 2026 |
| PMDA document key | 230971_3999457G1020_1 |
| PMDA company code | 230971 |
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: