PMDA drug package insert

リバスチグミンテープ4.5mg「アメル」

PMDA Prescription drug · 帝國製薬株式会社 · package insert Oct 30, 2024

Key facts

Brand names リバスチグミンテープ4.5mg「アメル」, リバスチグミンテープ9mg「アメル」, リバスチグミンテープ13.5mg「アメル」, リバスチグミンテープ18mg「アメル」
Nonproprietary names リバスチグミン
Companies 製造販売元/帝國製薬株式会社, 販売元/共和薬品工業株式会社
Product type Prescription drug
Therapeutic category アルツハイマー型認知症治療剤
Therapeutic category codes 87119
YJ codes 1190700S1088, 1190700S2084, 1190700S3080, 1190700S4087
Approval numbers 30200AMX00892000, 30200AMX00893000, 30200AMX00894000, 30200AMX00895000
Package insert edition 第2版
Package insert date Oct 30, 2024
PMDA document key 470006_1190700S1088_1
PMDA company code 470006

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:

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