PMDA drug package insert

ドロキシドパカプセル100mg「アメル」

PMDA Prescription drug · 共和薬品工業株式会社 · package insert Feb 27, 2025

Key facts

Brand names ドロキシドパカプセル100mg「アメル」, ドロキシドパカプセル200mg「アメル」
Nonproprietary names ドロキシドパ
Companies 製造販売元/共和薬品工業株式会社
Product type Prescription drug
Therapeutic category ノルアドレナリン作動性神経機能改善剤
Therapeutic category codes 871169
YJ codes 1169006M1034, 1169006M2030
Approval numbers 21800AMZ10333, 21800AMZ10334
Package insert edition 第2版
Package insert date Feb 27, 2025
PMDA document key 672173_1169006M1034_2
PMDA company code 672173

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)