PMDA drug package insert

レキサルティOD錠0.5mg

PMDA Prescription drug · 大塚製薬株式会社 · package insert Sep 24, 2024

Key facts

Brand names レキサルティOD錠0.5mg, レキサルティOD錠1mg, レキサルティOD錠2mg
Nonproprietary names ブレクスピプラゾール
Companies 製造販売元/大塚製薬株式会社
Product type Prescription drug
Therapeutic category 抗精神病薬
Therapeutic category codes 871179
YJ codes 1179058F3023, 1179058F4020, 1179058F5026
Approval numbers 30300AMX00429, 30300AMX00430, 30300AMX00431
Package insert edition 第5版
Package insert date Sep 24, 2024
PMDA document key 180078_1179058F3023_1
PMDA company code 180078

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes PMDA review report published
  • Yes 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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