PMDA drug package insert
グルファスト錠5mg
PMDA Prescription drug · キッセイ薬品工業株式会社 · package insert Dec 17, 2025
Key facts
| Brand names | グルファスト錠5mg, グルファスト錠10mg, グルファストOD錠5mg, グルファストOD錠10mg |
|---|---|
| Nonproprietary names | ミチグリニドカルシウム水和物 |
| Companies | 製造販売元／キッセイ薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 速効型インスリン分泌促進薬 |
| Therapeutic category codes | 873969 |
| YJ codes | 3969008F1029, 3969008F2025, 3969008F3021, 3969008F4028 |
| Approval numbers | 21600AMZ00035000, 21600AMZ00036000, 22800AMX00092000, 22800AMX00093000 |
| Package insert edition | 第3版 |
| Package insert date | Dec 17, 2025 |
| PMDA document key | 230034_3969008F1029_1 |
| PMDA company code | 230034 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: