PMDA drug package insert

ロメフロンミニムス眼科耳科用液0.3%

PMDA Prescription drug · 千寿製薬株式会社 · package insert Nov 1, 2022

Key facts

Brand names ロメフロンミニムス眼科耳科用液0.3%
Nonproprietary names 塩酸ロメフロキサシン
Companies 製造販売元/千寿製薬株式会社, 販売/武田薬品工業株式会社
Product type Prescription drug
Therapeutic category ニューキノロン系抗菌眼科耳科用剤
Therapeutic category codes 871319, 871329
YJ codes 1319734Q2030
Approval numbers 21900AMX01435
Package insert edition 第3版
Package insert date Nov 1, 2022
PMDA document key 380086_1319734Q2030_1
PMDA company code 380086

At a glance

  • 1–9 Package insert revisions
  • 1–9 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)