PMDA drug package insert
レパーサ皮下注140mgペン
PMDA Prescription drug · アムジェン株式会社 · package insert Jun 18, 2025
Key facts
| Brand names | レパーサ皮下注140mgペン |
|---|---|
| Nonproprietary names | エボロクマブ（遺伝子組換え） |
| Companies | 製造販売／アムジェン株式会社, 発売／アステラス製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト抗PCSK9モノクローナル抗体製剤 |
| Therapeutic category codes | 872189 |
| YJ codes | 2189401G2026 |
| Approval numbers | 22800AMX00023000 |
| Package insert edition | 第3版 |
| Package insert date | Jun 18, 2025 |
| PMDA document key | 112292_2189401G2026_2 |
| PMDA company code | 112292 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None 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: