PMDA drug package insert
オンボー皮下注100mgオートインジェクター
PMDA Prescription drug · 日本イーライリリー株式会社 · package insert Apr 16, 2026
Key facts
| Brand names | オンボー皮下注100mgオートインジェクター, オンボー皮下注200mgオートインジェクター, オンボー皮下注100mgシリンジ, オンボー皮下注200mgシリンジ |
|---|---|
| Nonproprietary names | ミリキズマブ（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, 販売／持田製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト化抗ヒトIL-23p19モノクローナル抗体製剤 |
| Therapeutic category codes | 87239 |
| YJ codes | 2399407G2020, 2399407G4023, 2399407G1024, 2399407G3027 |
| Approval numbers | 30500AMX00119, 30700AMX00067, 30500AMX00120, 30700AMX00068 |
| Package insert edition | 第7版 |
| Package insert date | Apr 16, 2026 |
| PMDA document key | 530471_2399407G1024_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: