PMDA drug package insert

ジルテック錠5

PMDA Prescription drug · ユーシービージャパン株式会社 · package insert Apr 1, 2025

Key facts

Brand names ジルテック錠5, ジルテック錠10
Nonproprietary names セチリジン塩酸塩
Companies 製造販売元/ユーシービージャパン株式会社
Product type Prescription drug
Therapeutic category 持続性選択H1受容体拮抗・アレルギー性疾患治療剤
Therapeutic category codes 87449
YJ codes 4490020F1020, 4490020F2027
Approval numbers 21000AMY00144, 21000AMY00145
Package insert edition 第2版
Package insert date Apr 1, 2025
PMDA document key 820110_4490020F1020_2
PMDA company code 820110

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)