PMDA drug package insert

アレグラ錠30mg

PMDA Prescription drug · サノフィ株式会社 · package insert May 8, 2024

Key facts

Brand names アレグラ錠30mg, アレグラ錠60mg
Nonproprietary names フェキソフェナジン塩酸塩
Companies 製造販売元/サノフィ株式会社
Product type Prescription drug
Therapeutic category アレルギー性疾患治療剤
Therapeutic category codes 87449
YJ codes 4490023F2020, 4490023F1024
Approval numbers 21800AMY10127, 21200AMY00202
Package insert edition 第3版
Package insert date May 8, 2024
PMDA document key 780069_4490023F1024_1
PMDA company code 780069

At a glance

  • 1–9 Package insert revisions
  • 10–99 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)