PMDA drug package insert

デュロキセチンカプセル20mg「オーハラ」

PMDA Prescription drug · 大原薬品工業株式会社 · package insert Jun 15, 2026

Key facts

Brand names デュロキセチンカプセル20mg「オーハラ」, デュロキセチンカプセル30mg「オーハラ」
Nonproprietary names デュロキセチン塩酸塩
Companies 製造販売元/大原薬品工業株式会社
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 1179052M1081, 1179052M2088
Approval numbers 30300AMX00103000, 30300AMX00104000
Package insert edition 第3版
Package insert date Jun 15, 2026
PMDA document key 180095_1179052M1081_1
PMDA company code 180095

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)