PMDA drug package insert

マプロチリン塩酸塩錠10mg「アメル」

PMDA Prescription drug · 共和薬品工業株式会社 · package insert Jan 24, 2025

Key facts

Brand names マプロチリン塩酸塩錠10mg「アメル」, マプロチリン塩酸塩錠25mg「アメル」
Nonproprietary names マプロチリン塩酸塩
Companies 製造販売元/共和薬品工業株式会社
Product type Prescription drug
Therapeutic category 四環系抗うつ剤
Therapeutic category codes 871179
YJ codes 1179008F1081, 1179008F2070
Approval numbers 22500AMX01958, 22500AMX01959
Package insert edition 第2版
Package insert date Jan 24, 2025
PMDA document key 672173_1179008F1081_2
PMDA company code 672173

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)