PMDA drug package insert
ケサンラ点滴静注液350mg
PMDA Prescription drug · 日本イーライリリー株式会社 · package insert Aug 17, 2026
Key facts
| Brand names | ケサンラ点滴静注液350mg |
|---|---|
| Nonproprietary names | ドナネマブ（遺伝子組換え） |
| Companies | 製造販売元／日本イーライリリー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト化抗N3pGアミロイドβ注2）モノクローナル抗体製剤 注2）N末端第3残基がピログルタミル化されたアミロイドβ |
| Therapeutic category codes | 87119 |
| YJ codes | 1190409A1020 |
| Approval numbers | 30600AMX00243 |
| Package insert edition | 第6版 |
| Package insert date | Aug 17, 2026 |
| PMDA document key | 530471_1190409A1020_1 |
| PMDA company code | 530471 |
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: