PMDA drug package insert

セレコキシブ錠100mg「オーハラ」

PMDA Prescription drug · 大原薬品工業株式会社 · package insert Dec 25, 2024

Key facts

Brand names セレコキシブ錠100mg「オーハラ」, セレコキシブ錠200mg「オーハラ」
Nonproprietary names セレコキシブ
Companies 製造販売元/大原薬品工業株式会社
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 1149037F1089, 1149037F2085
Approval numbers 30200AMX00367000, 30200AMX00368000
Package insert edition 第2版
Package insert date Dec 25, 2024
PMDA document key 180095_1149037F1089_1
PMDA company code 180095

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)