PMDA drug package insert

イストラデフィリン錠20mg「アメル」

PMDA Prescription drug · 共和薬品工業株式会社 · package insert Aug 27, 2026

Key facts

Brand names イストラデフィリン錠20mg「アメル」
Nonproprietary names イストラデフィリン
Companies 製造販売元/共和薬品工業株式会社
Product type Prescription drug
Therapeutic category アデノシンA2A受容体拮抗薬
Therapeutic category codes 871169
YJ codes 11690B0F2023
Approval numbers 30800AMX00279
Package insert edition 第1版
Package insert date Aug 27, 2026
PMDA document key 672173_11690B0F2023_1
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)