PMDA drug package insert
デュピクセント皮下注300mgペン
PMDA Prescription drug · サノフィ株式会社 · package insert Mar 23, 2026
Key facts
| Brand names | デュピクセント皮下注300mgペン, デュピクセント皮下注300mgシリンジ, デュピクセント皮下注200mgペン, デュピクセント皮下注200mgシリンジ |
|---|---|
| Nonproprietary names | デュピルマブ（遺伝子組換え） |
| Companies | 製造販売元／サノフィ株式会社, 販売提携／リジェネロン・ジャパン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト型抗ヒトIL-4/13受容体モノクローナル抗体 |
| Therapeutic category codes | 87449 |
| YJ codes | 4490405G2020, 4490405G1024, 4490405G4023, 4490405G3027 |
| Approval numbers | 30200AMX00926, 23000AMX00015, 30700AMX00125, 30500AMX00261 |
| Package insert edition | 第14版 |
| Package insert date | Mar 23, 2026 |
| PMDA document key | 780069_4490405G1024_1 |
| PMDA company code | 780069 |
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: