PMDA drug package insert
ケシンプタ皮下注20mgペン
PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Jul 1, 2026
Key facts
| Brand names | ケシンプタ皮下注20mgペン |
|---|---|
| Nonproprietary names | オファツムマブ（遺伝子組換え） |
| Companies | 製造販売（輸入）／ノバルティスファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 多発性硬化症治療剤/ヒト型抗CD20モノクローナル抗体 |
| Therapeutic category codes | 87119 |
| YJ codes | 1190405G1024 |
| Approval numbers | 30300AMX00257000 |
| Package insert edition | 第7版 |
| Package insert date | Jul 1, 2026 |
| PMDA document key | 300242_1190405G1024_1 |
| PMDA company code | 300242 |
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: