PMDA drug package insert
オングリザ錠2.5mg
PMDA Prescription drug · 協和キリン株式会社 · package insert Oct 20, 2025
Key facts
| Brand names | オングリザ錠2.5mg, オングリザ錠5mg |
|---|---|
| Nonproprietary names | サキサグリプチン水和物 |
| Companies | 製造販売元／協和キリン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 選択的DPP-4阻害剤 2型糖尿病治療剤 |
| Therapeutic category codes | 873969 |
| YJ codes | 3969017F1028, 3969017F2024 |
| Approval numbers | 22500AMX00877, 22500AMX00878 |
| Package insert edition | 第3版 |
| Package insert date | Oct 20, 2025 |
| PMDA document key | 230124_3969017F1028_1 |
| PMDA company code | 230124 |
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: