PMDA drug package insert

コレクチム軟膏0.5%

PMDA Prescription drug · 塩野義製薬株式会社 · package insert Dec 1, 2025

Key facts

Brand names コレクチム軟膏0.5%, コレクチム軟膏0.25%
Nonproprietary names デルゴシチニブ
Companies 製造販売元/塩野義製薬株式会社, 販売元/鳥居薬品株式会社
Product type Prescription drug
Therapeutic category 外用ヤヌスキナーゼ(JAK)阻害剤
Therapeutic category codes 872699
YJ codes 2699714M1029, 2699714M2025
Approval numbers 30200AMX00046000, 30300AMX00243000
Package insert edition 第7版
Package insert date Dec 1, 2025
PMDA document key 340018_2699714M1029_2
PMDA company code 340018

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None Safety communications
  • Yes PMDA review report published
  • Yes 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)