PMDA drug package insert
ジャディアンス錠10mg
PMDA Prescription drug · 日本ベーリンガーインゲルハイム株式会社 · package insert Sep 1, 2025
Key facts
| Brand names | ジャディアンス錠10mg, ジャディアンス錠25mg |
|---|---|
| Nonproprietary names | エンパグリフロジン |
| Companies | 製造販売元／日本ベーリンガーインゲルハイム株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 選択的SGLT2阻害剤 －2型糖尿病・慢性心不全・慢性腎臓病治療剤－; 選択的SGLT2阻害剤 －2型糖尿病治療剤－ |
| Therapeutic category codes | 873969, 87219, 873999 |
| YJ codes | 3969023F1023, 3969023F2020 |
| Approval numbers | 22600AMX01387000, 22600AMX01386000 |
| Package insert edition | 第8版 |
| Package insert date | Sep 1, 2025 |
| PMDA document key | 650168_3969023F1023_1 |
| PMDA company code | 650168 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: