PMDA drug package insert

グルベス配合錠

PMDA Prescription drug · キッセイ薬品工業株式会社 · package insert May 20, 2025

Key facts

Brand names グルベス配合錠
Nonproprietary names ミチグリニドカルシウム水和物・ボグリボース配合剤
Companies 製造販売元/キッセイ薬品工業株式会社
Product type Prescription drug
Therapeutic category 速効型インスリン分泌促進薬/食後過血糖改善薬配合剤
Therapeutic category codes 873969
YJ codes 3969102F1020
Approval numbers 22300AMX00512000
Package insert edition 第3版
Package insert date May 20, 2025
PMDA document key 230034_3969102F1020_1
PMDA company code 230034

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None 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)