PMDA drug package insert
レケンビ皮下注250mgペン
PMDA Prescription drug · エーザイ株式会社 · package insert Sep 16, 2026
Key facts
| Brand names | レケンビ皮下注250mgペン |
|---|---|
| Nonproprietary names | レカネマブ（遺伝子組換え） |
| Companies | 製造販売元／エーザイ株式会社, 販売提携／バイオジェン・ジャパン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト化抗ヒト可溶性アミロイドβ凝集体モノクローナル抗体 |
| Therapeutic category codes | 87119 |
| YJ codes | 11904A5G1028 |
| Approval numbers | 30800AMX00344000 |
| Package insert edition | 第1版 |
| Package insert date | Sep 16, 2026 |
| PMDA document key | 170033_11904A5G1028_1 |
| PMDA company code | 170033 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: