PMDA drug package insert
ミチグリニドCa・OD錠5mg「フソー」
PMDA Prescription drug · リョートーファイン株式会社 · package insert Oct 1, 2026
Key facts
| Brand names | ミチグリニドCa・OD錠5mg「フソー」, ミチグリニドCa・OD錠10mg「フソー」 |
|---|---|
| Nonproprietary names | ミチグリニドカルシウム水和物 |
| Companies | 製造販売元／リョートーファイン株式会社, 販売元／扶桑薬品工業株式会社 |
| 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 | 3969008F3072, 3969008F4079 |
| Approval numbers | 22800AMX00655000, 22800AMX00656000 |
| Package insert edition | 第2版 |
| Package insert date | Oct 1, 2026 |
| PMDA document key | 850079_3969008F3072_1 |
| PMDA company code | 850079 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- No 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: