PMDA drug package insert

メトホルミン塩酸塩錠250mgMT「DSPB」

PMDA Prescription drug · 住友ファーマプロモ株式会社 · package insert Nov 21, 2023

Key facts

Brand names メトホルミン塩酸塩錠250mgMT「DSPB」, メトホルミン塩酸塩錠500mgMT「DSPB」
Nonproprietary names メトホルミン塩酸塩
Companies 製造販売元/住友ファーマプロモ株式会社, 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 3962002F2124, 3962002F3120
Approval numbers 30200AMX00194, 30200AMX00195
Package insert edition 第5版
Package insert date Nov 21, 2023
PMDA document key 370242_3962002F2124_1
PMDA company code 370242

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)