PMDA drug package insert

ミケラン錠5mg

PMDA Prescription drug · 大塚製薬株式会社 · package insert May 16, 2023

Key facts

Brand names ミケラン錠5mg
Nonproprietary names カルテオロール塩酸塩
Companies 製造販売元/大塚製薬株式会社
Product type Prescription drug
Therapeutic category βブロッカー
Therapeutic category codes 872123
YJ codes 2123005F1141
Approval numbers 15500AMZ01615
Package insert edition 第1版
Package insert date May 16, 2023
PMDA document key 180078_2123005F1141_1
PMDA company code 180078

At a glance

  • 1–9 Package insert revisions
  • 1–9 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)