PMDA drug package insert

レメロン錠15mg

PMDA Prescription drug · オルガノン株式会社 · package insert Oct 18, 2024

Key facts

Brand names レメロン錠15mg, レメロン錠30mg
Nonproprietary names ミルタザピン
Companies 製造販売元/オルガノン株式会社
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 1179051F1037, 1179051F2033
Approval numbers 22100AMX01823000, 22800AMX00356000
Package insert edition 第6版
Package insert date Oct 18, 2024
PMDA document key 181615_1179051F1037_2
PMDA company code 181615

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 Safety communications
  • Yes 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)