PMDA drug package insert

スーグラ錠25mg

PMDA Prescription drug · アステラス製薬株式会社 · package insert Aug 28, 2025

Key facts

Brand names スーグラ錠25mg, スーグラ錠50mg
Nonproprietary names イプラグリフロジン L-プロリン
Companies 製造販売/アステラス製薬株式会社, 販売提携/寿製薬株式会社
Product type Prescription drug
Therapeutic category 選択的SGLT2阻害剤 -糖尿病治療剤-
Therapeutic category codes 873969
YJ codes 3969018F1022, 3969018F2029
Approval numbers 22600AMX00009, 22600AMX00010
Package insert edition 第5版
Package insert date Aug 28, 2025
PMDA document key 800126_3969018F1022_1
PMDA company code 800126

At a glance

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

Browse all PMDA approved drugs and package inserts (Japan)