PMDA drug package insert
ルミセフ皮下注210mgペン
PMDA Prescription drug · 協和キリン株式会社 · package insert Mar 18, 2026
Key facts
| Brand names | ルミセフ皮下注210mgペン, ルミセフ皮下注210mgシリンジ |
|---|---|
| Nonproprietary names | ブロダルマブ（遺伝子組換え） |
| Companies | 製造販売元／協和キリン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト型抗ヒトIL-17受容体Aモノクローナル抗体製剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999441G2025, 3999441G1029 |
| Approval numbers | 30700AMX00118, 22800AMX00441 |
| Package insert edition | 第8版 |
| Package insert date | Mar 18, 2026 |
| PMDA document key | 230124_3999441G1029_1 |
| PMDA company code | 230124 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- No 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: