PMDA drug package insert

5−FU軟膏5%協和

PMDA Prescription drug · 協和キリン株式会社 · package insert Feb 14, 2022

Key facts

Brand names 5−FU軟膏5%協和
Nonproprietary names フルオロウラシル
Companies 製造販売元/協和キリン株式会社
Product type Prescription drug
Therapeutic category 抗腫瘍外用剤
Therapeutic category codes 874223
YJ codes 4223701M1047
Approval numbers 21900AMX01263
Package insert edition 第1版
Package insert date Feb 14, 2022
PMDA document key 230124_4223701M1047_1
PMDA company code 230124

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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