PMDA drug package insert

ウルソデオキシコール酸錠50mg「トーワ」

PMDA Prescription drug · 東和薬品株式会社 · package insert Dec 1, 2025

Key facts

Brand names ウルソデオキシコール酸錠50mg「トーワ」, ウルソデオキシコール酸錠100mg「トーワ」
Nonproprietary names ウルソデオキシコール酸
Companies 製造販売元/東和薬品株式会社
Product type Prescription drug
Therapeutic category 肝・胆・消化機能改善剤
Therapeutic category codes 872362
YJ codes 2362001F1118, 2362001F2220
Approval numbers 22500AMX00722, 22500AMX00723
Package insert edition 第3版
Package insert date Dec 1, 2025
PMDA document key 480235_2362001F1118_1
PMDA company code 480235

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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