PMDA drug package insert

ウリトス錠0.1mg

PMDA Prescription drug · 杏林製薬株式会社 · package insert Jun 1, 2026

Key facts

Brand names ウリトス錠0.1mg, ウリトスOD錠0.1mg
Nonproprietary names イミダフェナシン
Companies 製造販売元/杏林製薬株式会社
Product type Prescription drug
Therapeutic category 過活動膀胱治療剤
Therapeutic category codes 87259
YJ codes 2590013F1027, 2590013F2023
Approval numbers 21900AMZ00066000, 22200AMX00986000
Package insert edition 第3版
Package insert date Jun 1, 2026
PMDA document key 231099_2590013F1027_2
PMDA company code 231099

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None 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:

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