PMDA drug package insert

コムクロシャンプー0.05%

PMDA Prescription drug · マルホ株式会社 · package insert Jan 31, 2023

Key facts

Brand names コムクロシャンプー0.05%
Nonproprietary names クロベタゾールプロピオン酸エステル
Companies 製造販売(輸入)/マルホ株式会社, 提携/GALDERMA
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 2646713Q2029
Approval numbers 22900AMX00531000
Package insert edition 第2版、再審査結果
Package insert date Jan 31, 2023
PMDA document key 730155_2646713Q2029_1
PMDA company code 730155

At a glance

  • 1–9 Package insert revisions
  • 1–9 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:

Browse all PMDA approved drugs and package inserts (Japan)