PMDA drug package insert

ビスダーム軟膏0.1%

PMDA Prescription drug · 帝國製薬株式会社 · package insert Nov 1, 2023

Key facts

Brand names ビスダーム軟膏0.1%, ビスダームクリーム0.1%
Nonproprietary names アムシノニド
Companies 製造販売元/帝國製薬株式会社
Product type Prescription drug
Therapeutic category 外用合成副腎皮質ホルモン剤
Therapeutic category codes 872646
YJ codes 2646718M1040, 2646718N1045
Approval numbers 22000AMX00124000, 22000AMX00123000
Package insert edition 第2版
Package insert date Nov 1, 2023
PMDA document key 470006_2646718M1040_2
PMDA company code 470006

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:

Browse all PMDA approved drugs and package inserts (Japan)