PMDA drug package insert

メトグルコ錠250mg

PMDA Prescription drug · 住友ファーマ株式会社 · package insert Nov 21, 2023

Key facts

Brand names メトグルコ錠250mg, メトグルコ錠500mg
Nonproprietary names メトホルミン塩酸塩
Companies 製造販売元/住友ファーマ株式会社, 提携/Merck Santé(フランス)
Product type Prescription drug
Therapeutic category ビグアナイド系経口血糖降下剤
Therapeutic category codes 873962
YJ codes 3962002F2027, 3962002F3023
Approval numbers 22200AMX00234, 22400AMX01367
Package insert edition 第5版
Package insert date Nov 21, 2023
PMDA document key 400093_3962002F2027_1
PMDA company code 400093

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)