PMDA drug package insert

ワンデュロパッチ0.84mg

PMDA Prescription drug · ヤンセンファーマ株式会社 · package insert Dec 23, 2024

Key facts

Brand names ワンデュロパッチ0.84mg, ワンデュロパッチ1.7mg, ワンデュロパッチ3.4mg, ワンデュロパッチ5mg, ワンデュロパッチ6.7mg
Nonproprietary names フェンタニル
Companies 製造販売元(輸入)/ヤンセンファーマ株式会社
Product type Prescription drug
Therapeutic category 経皮吸収型 持続性疼痛治療剤
Therapeutic category codes 878219
YJ codes 8219700T1026, 8219700T2022, 8219700T3029, 8219700T4025, 8219700T5021
Approval numbers 22200AMX00950000, 22200AMX00951000, 22200AMX00952000, 22200AMX00953000, 22200AMX00954000
Package insert edition 第3版
Package insert date Dec 23, 2024
PMDA document key 800155_8219700T1026_1
PMDA company code 800155

At a glance

  • 1–9 Package insert revisions
  • 10–99 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)