PMDA drug package insert

アモキサンカプセル10mg

PMDA Prescription drug · ファイザー株式会社 · package insert Nov 30, 2021

Key facts

Brand names アモキサンカプセル10mg, アモキサンカプセル25mg, アモキサンカプセル50mg, アモキサン細粒10%
Nonproprietary names アモキサピン
Companies 製造販売元/ファイザー株式会社
Product type Prescription drug
Therapeutic category うつ病・うつ状態治療剤
Therapeutic category codes 871179
YJ codes 1179001M1020, 1179001M2026, 1179001M3022, 1179001C1024
Approval numbers 15500AMZ00853, 15500AMZ00854, 15500AMZ00855, 16200AMZ00207
Package insert edition 第1版
Package insert date Nov 30, 2021
PMDA document key 672212_1179001C1024_3
PMDA company code 672212

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)