PMDA drug package insert

ミチグリニドCa・OD錠5mg「TCK」

PMDA Prescription drug · 辰巳化学株式会社 · package insert Apr 30, 2026

Key facts

Brand names ミチグリニドCa・OD錠5mg「TCK」, ミチグリニドCa・OD錠10mg「TCK」
Nonproprietary names ミチグリニドカルシウム水和物
Companies 製造販売元/辰巳化学株式会社
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 3969008F3056, 3969008F4052
Approval numbers 22800AMX00662000, 22800AMX00663000
Package insert edition 第2版
Package insert date Apr 30, 2026
PMDA document key 400278_3969008F3056_1
PMDA company code 400278

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:

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