PMDA drug package insert

アトモキセチン錠5mg「ニプロ」

PMDA Prescription drug · ニプロ株式会社 · package insert Oct 1, 2023

Key facts

Brand names アトモキセチン錠5mg「ニプロ」, アトモキセチン錠10mg「ニプロ」, アトモキセチン錠25mg「ニプロ」, アトモキセチン錠40mg「ニプロ」
Nonproprietary names アトモキセチン塩酸塩
Companies 製造販売元/ニプロ株式会社
Product type Prescription drug
Therapeutic category 注意欠陥/多動性障害治療剤(選択的ノルアドレナリン再取り込み阻害剤)
Therapeutic category codes 871179
YJ codes 1179050F1059, 1179050F2055, 1179050F3051, 1179050F4058
Approval numbers 23000AMX00711, 23000AMX00712, 23000AMX00713, 23000AMX00714
Package insert edition 第1版
Package insert date Oct 1, 2023
PMDA document key 530100_1179050F1059_1
PMDA company code 530100

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)