PMDA drug package insert

ピタバスタチンCa・OD錠1mg「杏林」

PMDA Prescription drug · キョーリンリメディオ株式会社 · package insert Mar 5, 2025

Key facts

Brand names ピタバスタチンCa・OD錠1mg「杏林」, ピタバスタチンCa・OD錠2mg「杏林」, ピタバスタチンCa・OD錠4mg「杏林」
Nonproprietary names ピタバスタチンカルシウム
Companies 製造販売元/キョーリンリメディオ株式会社, 販売元/杏林製薬株式会社
Product type Prescription drug
Therapeutic category HMG-CoA還元酵素阻害剤
Therapeutic category codes 872189
YJ codes 2189016F4086, 2189016F5082, 2189016F6070
Approval numbers 22800AMX00637000, 22800AMX00638000, 22800AMX00639000
Package insert edition 第3版
Package insert date Mar 5, 2025
PMDA document key 480209_2189016F4086_1
PMDA company code 480209

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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