PMDA drug package insert
オラデオ顆粒分包72mg
PMDA Prescription drug · 株式会社オーファンパシフィック · package insert Aug 28, 2026
Key facts
| Brand names | オラデオ顆粒分包72mg, オラデオ顆粒分包96mg, オラデオ顆粒分包108mg, オラデオ顆粒分包132mg |
|---|---|
| Nonproprietary names | ベロトラルスタット塩酸塩 |
| Companies | 製造販売元／株式会社オーファンパシフィック, 販売提携／鳥居薬品株式会社, 提携／バイオクリスト・ジャパン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝性血管性浮腫発作抑制用 血漿カリクレイン阻害剤 |
| Therapeutic category codes | 87449 |
| YJ codes | 44900C3D1027, 44900C3D2023, 44900C3D3020, 44900C3D4026 |
| Approval numbers | 30800AMX00300000, 30800AMX00297000, 30800AMX00298000, 30800AMX00299000 |
| Package insert edition | 第1版 |
| Package insert date | Aug 28, 2026 |
| PMDA document key | 181251_44900C3D2023_1 |
| PMDA company code | 181251 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: