PMDA drug package insert

リバゼブ配合錠LD

PMDA Prescription drug · 興和株式会社 · package insert Jul 20, 2023

Key facts

Brand names リバゼブ配合錠LD, リバゼブ配合錠HD
Nonproprietary names ピタバスタチンカルシウム水和物・エゼチミブ配合剤
Companies 製造販売元/興和株式会社
Product type Prescription drug
Therapeutic category HMG-CoA還元酵素阻害剤/小腸コレステロールトランスポーター阻害剤配合剤
Therapeutic category codes 872189
YJ codes 2189103F1029, 2189103F2025
Approval numbers 30400AMX00415, 30400AMX00416
Package insert edition 第3版
Package insert date Jul 20, 2023
PMDA document key 270072_2189103F1029_1
PMDA company code 270072

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:

Browse all PMDA approved drugs and package inserts (Japan)