PMDA drug package insert
エクテリー錠300mg
PMDA Prescription drug · キエジ・ファーマ・ジャパン株式会社 · package insert Sep 24, 2026
Key facts
| Brand names | エクテリー錠300mg |
|---|---|
| Nonproprietary names | セベトラルスタット |
| Companies | 選任外国製造医薬品等製造販売業者／キエジ・ファーマ・ジャパン株式会社, 外国製造医薬品等特例承認取得者／KalVista Pharmaceuticals Ltd.（英国）, 発売元／科研製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝性血管性浮腫（HAE）急性発作治療用血漿カリクレイン阻害薬 |
| Therapeutic category codes | 87449 |
| YJ codes | 4490038F1020 |
| Approval numbers | 30700AMI00004000 |
| Package insert edition | 第3版 |
| Package insert date | Sep 24, 2026 |
| PMDA document key | 231120_4490038F1020_A |
| PMDA company code | 231120 |
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: