PMDA drug package insert

デュロキセチンカプセル20mg「DSEP」

PMDA Prescription drug · 第一三共エスファ株式会社 · package insert Jun 25, 2026

Key facts

Brand names デュロキセチンカプセル20mg「DSEP」, デュロキセチンカプセル30mg「DSEP」
Nonproprietary names デュロキセチン塩酸塩
Companies 製造販売元/第一三共エスファ株式会社, 販売提携/第一三共株式会社
Product type Prescription drug
Therapeutic category セロトニン・ノルアドレナリン再取り込み阻害剤
Therapeutic category codes 871179, 87119
YJ codes 1179052M1030, 1179052M2037
Approval numbers 30300AMX00143, 30300AMX00144
Package insert edition 第4版
Package insert date Jun 25, 2026
PMDA document key 430773_1179052M1030_1
PMDA company code 430773

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)