PMDA drug package insert
グレースビット錠50mg
PMDA Prescription drug · 第一三共株式会社 · package insert Mar 5, 2025
Key facts
| Brand names | グレースビット錠50mg, グレースビット細粒10% |
|---|---|
| Nonproprietary names | シタフロキサシン水和物 |
| Companies | 製造販売元／第一三共株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 広範囲経口抗菌製剤 |
| Therapeutic category codes | 876241 |
| YJ codes | 6241018F1027, 6241018C1020 |
| Approval numbers | 22000AMX00015, 22000AMX00016 |
| Package insert edition | 第2版 |
| Package insert date | Mar 5, 2025 |
| PMDA document key | 430574_6241018C1020_1 |
| PMDA company code | 430574 |
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: