PMDA drug package insert

モルヒネ塩酸塩注射液10mg「シオノギ」

PMDA Prescription drug · シオノギファーマ株式会社 · package insert Nov 13, 2024

Key facts

Brand names モルヒネ塩酸塩注射液10mg「シオノギ」, モルヒネ塩酸塩注射液50mg「シオノギ」
Nonproprietary names モルヒネ塩酸塩水和物
Companies 製造販売元/シオノギファーマ株式会社, 販売元/塩野義製薬株式会社
Product type Prescription drug
Therapeutic category モルヒネ系製剤
Therapeutic category codes 878114
YJ codes 8114401A1112, 8114401A2119
Approval numbers 22000AMX01076000, 22000AMX01077000
Package insert edition 第3版
Package insert date Nov 13, 2024
PMDA document key 343018_8114401A1112_2
PMDA company code 343018

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:

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