PMDA drug package insert

ウルソデオキシコール酸錠100mg「ZE」

PMDA Prescription drug · 全星薬品工業株式会社 · package insert Sep 16, 2026

Key facts

Brand names ウルソデオキシコール酸錠100mg「ZE」
Nonproprietary names ウルソデオキシコール酸
Companies 製造販売元/全星薬品工業株式会社, 発売元/全星薬品株式会社
Product type Prescription drug
Therapeutic category 肝・胆・消化機能改善剤
Therapeutic category codes 872362
YJ codes 2362001F2173
Approval numbers 22000AMX02352000
Package insert edition 第2版
Package insert date Sep 16, 2026
PMDA document key 380087_2362001F2173_1
PMDA company code 380087

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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