PMDA drug package insert

プラバスタチンNa錠5mg「チョーセイ」

PMDA Prescription drug · 長生堂製薬株式会社 · package insert Sep 9, 2024

Key facts

Brand names プラバスタチンNa錠5mg「チョーセイ」, プラバスタチンNa錠10mg「チョーセイ」
Nonproprietary names プラバスタチンナトリウム
Companies 製造販売元/長生堂製薬株式会社, 販売元/日本ジェネリック株式会社
Product type Prescription drug
Therapeutic category HMG-CoA還元酵素阻害剤 高脂血症治療剤
Therapeutic category codes 872189
YJ codes 2189010F1241, 2189010F2272
Approval numbers 21600AMZ00568000, 21600AMZ00569000
Package insert edition 第3版
Package insert date Sep 9, 2024
PMDA document key 450064_2189010F1241_3
PMDA company code 450064

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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