PMDA drug package insert
オプジーボ点滴静注20mg
PMDA Prescription drug · 小野薬品工業株式会社 · package insert Sep 29, 2026
Key facts
| Brand names | オプジーボ点滴静注20mg, オプジーボ点滴静注100mg, オプジーボ点滴静注120mg, オプジーボ点滴静注240mg |
|---|---|
| Nonproprietary names | ニボルマブ（遺伝子組換え） |
| Companies | 製造販売／小野薬品工業株式会社, プロモーション提携／ブリストル・マイヤーズ スクイブ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | －抗悪性腫瘍剤－ ヒト型抗ヒトPD-1モノクローナル抗体 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291427A1024, 4291427A2020, 4291427A4023, 4291427A3027 |
| Approval numbers | 22600AMX00768000, 22600AMX00769000, 30200AMX00925000, 23000AMX00812000 |
| Package insert edition | 第30版 |
| Package insert date | Sep 29, 2026 |
| PMDA document key | 180188_4291427A1024_1 |
| PMDA company code | 180188 |
At a glance
- 1–9 Package insert revisions
- 100–999 Related PMDA documents
- 1–9 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: