PMDA drug package insert

アンペック坐剤10mg

PMDA Prescription drug · 住友ファーマ株式会社 · package insert Nov 13, 2024

Key facts

Brand names アンペック坐剤10mg, アンペック坐剤20mg, アンペック坐剤30mg
Nonproprietary names モルヒネ塩酸塩水和物
Companies 製造販売元/住友ファーマ株式会社
Product type Prescription drug
Therapeutic category がん疼痛治療剤
Therapeutic category codes 878114
YJ codes 8114700J1023, 8114700J2020, 8114700J3026
Approval numbers 20300AMZ00742, 20300AMZ00743, 21100AMZ00431
Package insert edition 第3版
Package insert date Nov 13, 2024
PMDA document key 400093_8114700J1023_1
PMDA company code 400093

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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