PMDA drug package insert
フェブリク錠10mg
PMDA Prescription drug · 帝人ファーマ株式会社 · package insert Sep 2, 2024
Key facts
| Brand names | フェブリク錠10mg, フェブリク錠20mg, フェブリク錠40mg |
|---|---|
| Nonproprietary names | フェブキソスタット |
| Companies | 製造販売元／帝人ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 非プリン型選択的キサンチンオキシダーゼ阻害剤; 高尿酸血症治療剤 |
| Therapeutic category codes | 873949 |
| YJ codes | 3949003F1023, 3949003F2020, 3949003F3026 |
| Approval numbers | 22300AMX00419000, 22300AMX00421000, 22300AMX00420000 |
| Package insert edition | 第6版 |
| Package insert date | Sep 2, 2024 |
| PMDA document key | 470310_3949003F1023_1 |
| PMDA company code | 470310 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: