PMDA drug package insert

ケトプロフェン坐剤50mg「JG」

PMDA Prescription drug · 長生堂製薬株式会社 · package insert Oct 8, 2024

Key facts

Brand names ケトプロフェン坐剤50mg「JG」, ケトプロフェン坐剤75mg「JG」
Nonproprietary names ケトプロフェン
Companies 製造販売元/長生堂製薬株式会社, 販売元/日本ジェネリック株式会社
Product type Prescription drug
Therapeutic category 抗炎症・鎮痛・解熱剤
Therapeutic category codes 871149
YJ codes 1149700J1108, 1149700J2104
Approval numbers 22500AMX01073000, 22500AMX01074000
Package insert edition 第3版
Package insert date Oct 8, 2024
PMDA document key 450064_1149700J1108_1
PMDA company code 450064

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)