PMDA drug package insert

フェブキソスタット錠10mg「日新」

PMDA Prescription drug · 日新製薬株式会社 · package insert Dec 12, 2024

Key facts

Brand names フェブキソスタット錠10mg「日新」, フェブキソスタット錠20mg「日新」, フェブキソスタット錠40mg「日新」
Nonproprietary names フェブキソスタット
Companies 製造販売元/日新製薬株式会社
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 3949003F1120, 3949003F2127, 3949003F3123
Approval numbers 30400AMX00070, 30400AMX00071, 30400AMX00072
Package insert edition 第5版
Package insert date Dec 12, 2024
PMDA document key 530113_3949003F1120_1
PMDA company code 530113

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)