PMDA drug package insert

フェブキソスタット錠10mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Jan 8, 2025

Key facts

Brand names フェブキソスタット錠10mg「サワイ」, フェブキソスタット錠20mg「サワイ」, フェブキソスタット錠40mg「サワイ」, フェブキソスタットOD錠10mg「サワイ」, フェブキソスタットOD錠20mg「サワイ」
Nonproprietary names フェブキソスタット
Companies 製造販売元/沢井製薬株式会社
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 3949003F1104, 3949003F2100, 3949003F3107, 3949003F4049, 3949003F5045
Approval numbers 30400AMX00136000, 30400AMX00137000, 30400AMX00138000, 30400AMX00118000, 30400AMX00119000
Package insert edition 第6版
Package insert date Jan 8, 2025
PMDA document key 300119_3949003F1104_1
PMDA company code 300119

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:

Browse all PMDA approved drugs and package inserts (Japan)