PMDA drug package insert

ナルラピド錠1mg

PMDA Prescription drug · 第一三共株式会社 · package insert Jul 7, 2026

Key facts

Brand names ナルラピド錠1mg, ナルラピド錠2mg, ナルラピド錠4mg
Nonproprietary names ヒドロモルフォン塩酸塩
Companies 製造販売元/第一三共株式会社
Product type Prescription drug
Therapeutic category がん疼痛治療剤
Therapeutic category codes 878119
YJ codes 8119003F1023, 8119003F2020, 8119003F3026
Approval numbers 22900AMX00519, 22900AMX00520, 22900AMX00521
Package insert edition 第7版
Package insert date Jul 7, 2026
PMDA document key 430574_8119003F1023_2
PMDA company code 430574

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)