PMDA drug package insert

プロトピック軟膏0.03%小児用

PMDA Prescription drug · マルホ株式会社 · package insert Dec 8, 2021

Key facts

Brand names プロトピック軟膏0.03%小児用
Nonproprietary names タクロリムス水和物
Companies 製造販売/マルホ株式会社
Product type Prescription drug
Therapeutic category アトピー性皮膚炎治療剤(免疫抑制外用剤)
Therapeutic category codes 872699
YJ codes 2699709M2024
Approval numbers 21500AMZ00458000
Package insert edition 第2版、再審査結果
Package insert date Dec 8, 2021
PMDA document key 730155_2699709M2024_3
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)