PMDA drug package insert

ミチグリニドCa・OD錠5mg「SN」

PMDA Prescription drug · シオノケミカル株式会社 · package insert Oct 4, 2023

Key facts

Brand names ミチグリニドCa・OD錠5mg「SN」, ミチグリニドCa・OD錠10mg「SN」
Nonproprietary names ミチグリニドカルシウム水和物
Companies 製造販売元/シオノケミカル株式会社, 販売元/江州製薬株式会社
Product type Prescription drug
Therapeutic category 速効型インスリン分泌促進薬
Therapeutic category codes 873969
YJ codes 3969008F3080, 3969008F4087
Approval numbers 30100AMX00128000, 30100AMX00129000
Package insert edition 第1版
Package insert date Oct 4, 2023
PMDA document key 340409_3969008F3080_1
PMDA company code 340409

At a glance

  • 1–9 Package insert revisions
  • 1–9 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)