PMDA drug package insert

ミグリトールOD錠25mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Jun 30, 2023

Key facts

Brand names ミグリトールOD錠25mg「サワイ」, ミグリトールOD錠50mg「サワイ」, ミグリトールOD錠75mg「サワイ」
Nonproprietary names ミグリトール
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category 糖尿病食後過血糖改善剤
Therapeutic category codes 873969
YJ codes 3969009F6033, 3969009F4030, 3969009F5037
Approval numbers 22900AMX00324000, 22900AMX00325000, 22900AMX00326000
Package insert edition 第1版
Package insert date Jun 30, 2023
PMDA document key 300119_3969009F4030_1
PMDA company code 300119

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • No 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)