PMDA drug package insert

ルセフィ錠2.5mg

PMDA Prescription drug · 大正製薬株式会社 · package insert Mar 23, 2026

Key facts

Brand names ルセフィ錠2.5mg, ルセフィ錠5mg
Nonproprietary names ルセオグリフロジン水和物
Companies 製造販売/大正製薬株式会社
Product type Prescription drug
Therapeutic category 選択的SGLT2阻害剤 -2型糖尿病治療剤-
Therapeutic category codes 873969
YJ codes 3969020F1020, 3969020F2026
Approval numbers 22600AMX00540000, 22600AMX00541000
Package insert edition 第3版
Package insert date Mar 23, 2026
PMDA document key 400059_3969020F1020_1
PMDA company code 400059

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 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:

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