PMDA drug package insert

イニシンク配合錠

PMDA Prescription drug · 帝人ファーマ株式会社 · package insert Oct 22, 2025

Key facts

Brand names イニシンク配合錠
Nonproprietary names アログリプチン安息香酸塩・メトホルミン塩酸塩配合剤
Companies 製造販売元/帝人ファーマ株式会社, 販売/武田薬品工業株式会社
Product type Prescription drug
Therapeutic category 選択的DPP-4阻害薬/ビグアナイド系薬配合剤; -2型糖尿病治療剤-
Therapeutic category codes 873969
YJ codes 3969105F1023
Approval numbers 22800AMX00681000
Package insert edition 第5版
Package insert date Oct 22, 2025
PMDA document key 470310_3969105F1023_2
PMDA company code 470310

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)