PMDA drug package insert

アトルバスタチン錠5mg「Me」

PMDA Prescription drug · Meファルマ株式会社 · package insert Nov 21, 2023

Key facts

Brand names アトルバスタチン錠5mg「Me」, アトルバスタチン錠10mg「Me」
Nonproprietary names アトルバスタチンカルシウム水和物
Companies 製造販売元/Meファルマ株式会社, 販売元/共創未来ファーマ株式会社
Product type Prescription drug
Therapeutic category HMG-CoA還元酵素阻害剤
Therapeutic category codes 872189
YJ codes 2189015F1236, 2189015F2232
Approval numbers 22400AMX01166000, 22400AMX01167000
Package insert edition 第3版
Package insert date Nov 21, 2023
PMDA document key 171950_2189015F1236_3
PMDA company code 171950

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:

Browse all PMDA approved drugs and package inserts (Japan)