PMDA drug package insert
ウロミテキサン注100mg
PMDA Prescription drug · 塩野義製薬株式会社 · package insert Jun 29, 2023
Key facts
| Brand names | ウロミテキサン注100mg, ウロミテキサン注400mg |
|---|---|
| Nonproprietary names | メスナ |
| Companies | 製造販売元／塩野義製薬株式会社, 提携／ドイツ バクスター社 |
| Product type | Prescription drug |
| Therapeutic category | イホスファミド、シクロホスファミド泌尿器系障害発現抑制剤 |
| Therapeutic category codes | 873929 |
| YJ codes | 3929406A1020, 3929406A2026 |
| Approval numbers | 20600AMZ01447000, 20600AMZ01449000 |
| Package insert edition | 第1版 |
| Package insert date | Jun 29, 2023 |
| PMDA document key | 340018_3929406A1020_1 |
| PMDA company code | 340018 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: