PMDA drug package insert
ナノゾラ皮下注30mgシリンジ
PMDA Prescription drug · 大正製薬株式会社 · package insert Apr 17, 2025
Key facts
| Brand names | ナノゾラ皮下注30mgシリンジ, ナノゾラ皮下注30mgオートインジェクター |
|---|---|
| Nonproprietary names | オゾラリズマブ（遺伝子組換え） |
| Companies | 製造販売／大正製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | TNFα阻害薬 （一本鎖ヒト化抗ヒトTNFαモノクローナル抗体製剤） |
| Therapeutic category codes | 873999 |
| YJ codes | 3999467G1023, 3999467G2020 |
| Approval numbers | 30400AMX00401000, 30500AMX00172000 |
| Package insert edition | 第4版 |
| Package insert date | Apr 17, 2025 |
| PMDA document key | 400059_3999467G1023_1 |
| PMDA company code | 400059 |
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: