PMDA drug package insert
オレンシア皮下注125mgシリンジ1mL
PMDA Prescription drug · ブリストル・マイヤーズ スクイブ株式会社 · package insert May 21, 2026
Key facts
| Brand names | オレンシア皮下注125mgシリンジ1mL, オレンシア皮下注125mgオートインジェクター1mL |
|---|---|
| Nonproprietary names | アバタセプト（遺伝子組換え） |
| Companies | 製造販売元（輸入）／ブリストル・マイヤーズ スクイブ株式会社, 販売元／小野薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | T細胞選択的共刺激調節剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999429G1028, 3999429G2024 |
| Approval numbers | 22500AMX01002000, 22800AMX00359000 |
| Package insert edition | 第4版 |
| Package insert date | May 21, 2026 |
| PMDA document key | 670605_3999429G1028_2 |
| PMDA company code | 670605 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 Safety communications
- Yes PMDA review report published
- No 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: