PMDA drug package insert

オキシコドン徐放錠5mgNX「第一三共」

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

Key facts

Brand names オキシコドン徐放錠5mgNX「第一三共」, オキシコドン徐放錠10mgNX「第一三共」, オキシコドン徐放錠20mgNX「第一三共」, オキシコドン徐放錠40mgNX「第一三共」
Nonproprietary names オキシコドン塩酸塩水和物
Companies 製造販売元/第一三共株式会社
Product type Prescription drug
Therapeutic category 持続性がん疼痛治療剤
Therapeutic category codes 878119
YJ codes 8119002G5038, 8119002G6034, 8119002G7030, 8119002G8037
Approval numbers 23100AMX00272, 23100AMX00273, 23100AMX00274, 23100AMX00275
Package insert edition 第4版
Package insert date Apr 1, 2025
PMDA document key 430574_8119002G5038_2
PMDA company code 430574

At a glance

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