PMDA drug package insert
レボフロキサシン点滴静注バッグ500mg/100mL「DSEP」
PMDA Prescription drug · 第一三共エスファ株式会社 · package insert May 20, 2025
Key facts
| Brand names | レボフロキサシン点滴静注バッグ500mg/100mL「DSEP」, レボフロキサシン点滴静注500mg/20mL「DSEP」 |
|---|---|
| Nonproprietary names | レボフロキサシン水和物 |
| Companies | 製造販売元／第一三共エスファ株式会社, 販売提携／第一三共株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ニューキノロン系注射用抗菌製剤 |
| Therapeutic category codes | 876241 |
| YJ codes | 6241402G1032, 6241402A1030 |
| Approval numbers | 23000AMX00199, 23000AMX00198 |
| Package insert edition | 第1版 |
| Package insert date | May 20, 2025 |
| PMDA document key | 430773_6241402A1030_1 |
| PMDA company code | 430773 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: