PMDA drug package insert

フェンタニル注射液0.1mg「第一三共」

PMDA Prescription drug · 第一三共株式会社 · package insert Apr 1, 2025

Key facts

Brand names フェンタニル注射液0.1mg「第一三共」, フェンタニル注射液0.25mg「第一三共」
Nonproprietary names フェンタニルクエン酸塩
Companies 製造販売元/第一三共株式会社
Product type Prescription drug
Therapeutic category 麻酔用鎮痛剤
Therapeutic category codes 878219
YJ codes 8219400A1063, 8219400A2051
Approval numbers 22100AMX00476, 22100AMX00477
Package insert edition 第4版
Package insert date Apr 1, 2025
PMDA document key 430574_8219400A1063_2
PMDA company code 430574

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None 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)