PMDA drug package insert

クアゼパム錠15mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Feb 29, 2024

Key facts

Brand names クアゼパム錠15mg「サワイ」, クアゼパム錠20mg「サワイ」
Nonproprietary names クアゼパム
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category 睡眠障害改善剤
Therapeutic category codes 871124
YJ codes 1124030F1088, 1124030F2076
Approval numbers 22000AMX01121000, 22000AMX01119000
Package insert edition 第1版
Package insert date Feb 29, 2024
PMDA document key 300119_1124030F1088_1
PMDA company code 300119

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 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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