PMDA drug package insert

モルヒネ塩酸塩注射液10mg「第一三共」

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

Key facts

Brand names モルヒネ塩酸塩注射液10mg「第一三共」, モルヒネ塩酸塩注射液50mg「第一三共」
Nonproprietary names モルヒネ塩酸塩水和物
Companies 製造販売元/第一三共株式会社
Product type Prescription drug
Therapeutic category モルヒネ系製剤
Therapeutic category codes 878114
YJ codes 8114401A1120, 8114401A2127
Approval numbers 22000AMX02260, 22000AMX02229
Package insert edition 第4版
Package insert date Apr 1, 2025
PMDA document key 430574_8114401A1120_2
PMDA company code 430574

At a glance

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