PMDA drug package insert

エプレレノン錠25mg「杏林」

PMDA Prescription drug · キョーリンリメディオ株式会社 · package insert Mar 17, 2026

Key facts

Brand names エプレレノン錠25mg「杏林」, エプレレノン錠50mg「杏林」, エプレレノン錠100mg「杏林」
Nonproprietary names エプレレノン
Companies 製造販売元/キョーリンリメディオ株式会社, 販売元/杏林製薬株式会社
Product type Prescription drug
Therapeutic category 選択的ミネラルコルチコイド受容体拮抗薬
Therapeutic category codes 872149
YJ codes 2149045F1037, 2149045F2033, 2149045F3030
Approval numbers 30500AMX00057000, 30500AMX00056000, 30500AMX00055000
Package insert edition 第8版
Package insert date Mar 17, 2026
PMDA document key 480209_2149045F1037_1
PMDA company code 480209

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)