PMDA drug package insert

セレコキシブ錠100mg「ダイト」

PMDA Prescription drug · ダイト株式会社 · package insert Dec 6, 2024

Key facts

Brand names セレコキシブ錠100mg「ダイト」, セレコキシブ錠200mg「ダイト」
Nonproprietary names セレコキシブ
Companies 製造販売元/ダイト株式会社, 販売元/共創未来ファーマ株式会社
Product type Prescription drug
Therapeutic category 非ステロイド性消炎・鎮痛剤(COX-2選択的阻害剤)
Therapeutic category codes 871149
YJ codes 1149037F1232, 1149037F2239
Approval numbers 30500AMX00286000, 30500AMX00287000
Package insert edition 第3版
Package insert date Dec 6, 2024
PMDA document key 400073_1149037F1232_1
PMDA company code 400073

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 Safety communications
  • No 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)