PMDA drug package insert

ミルタザピン錠15mg「EE」

PMDA Prescription drug · 日医工株式会社 · package insert Oct 31, 2025

Key facts

Brand names ミルタザピン錠15mg「EE」, ミルタザピン錠30mg「EE」
Nonproprietary names ミルタザピン
Companies 製造販売元/日医工株式会社
Product type Prescription drug
Therapeutic category ノルアドレナリン・セロトニン作動性抗うつ剤
Therapeutic category codes 871179
YJ codes 1179051F1045, 1179051F2041
Approval numbers 23000AMX00679000, 23000AMX00678000
Package insert edition 第2版
Package insert date Oct 31, 2025
PMDA document key 530169_1179051F1045_2
PMDA company code 530169

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)