PMDA drug package insert
マリゼブ錠12.5mg
PMDA Prescription drug · キッセイ薬品工業株式会社 · package insert Oct 8, 2025
Key facts
| Brand names | マリゼブ錠12.5mg, マリゼブ錠25mg |
|---|---|
| Nonproprietary names | オマリグリプチン |
| Companies | 製造販売元／キッセイ薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 持続性選択的DPP-4阻害剤; ◎経口糖尿病用剤◎ |
| Therapeutic category codes | 873969 |
| YJ codes | 3969025F1022, 3969025F2029 |
| Approval numbers | 22700AMX01014000, 22700AMX01015000 |
| Package insert edition | 第5版 |
| Package insert date | Oct 8, 2025 |
| PMDA document key | 230034_3969025F1022_2 |
| PMDA company code | 230034 |
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: