PMDA drug package insert
エルレフィオ皮下注44mg
PMDA Prescription drug · ファイザー株式会社 · package insert Mar 17, 2026
Key facts
| Brand names | エルレフィオ皮下注44mg, エルレフィオ皮下注76mg |
|---|---|
| Nonproprietary names | エルラナタマブ（遺伝子組換え） |
| Companies | 製造販売元／ファイザー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤; 抗BCMA/CD3二重特異性抗体 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291470A1020, 4291470A2027 |
| Approval numbers | 30600AMX00121, 30600AMX00122 |
| Package insert edition | 第4版 |
| Package insert date | Mar 17, 2026 |
| PMDA document key | 672212_4291470A1020_1 |
| PMDA company code | 672212 |
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: