PMDA drug package insert
オゼックス細粒小児用15%
PMDA Prescription drug · 富士フイルム富山化学株式会社 · package insert Nov 26, 2025
Key facts
| Brand names | オゼックス細粒小児用15%, オゼックス錠小児用60mg |
|---|---|
| Nonproprietary names | トスフロキサシントシル酸塩水和物 |
| Companies | 製造販売元／富士フイルム富山化学株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ニューキノロン系経口抗菌製剤 |
| Therapeutic category codes | 876241 |
| YJ codes | 6241010C1024, 6241010F3023 |
| Approval numbers | 22100AMX02267000, 23000AMX00239000 |
| Package insert edition | 第3版 |
| Package insert date | Nov 26, 2025 |
| PMDA document key | 400022_6241010C1024_2 |
| PMDA company code | 400022 |
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: