PMDA drug package insert

オフロキサシン耳科用液0.3%「CEO」

PMDA Prescription drug · セオリアファーマ株式会社 · package insert Jan 26, 2024

Key facts

Brand names オフロキサシン耳科用液0.3%「CEO」
Nonproprietary names オフロキサシン
Companies 製造販売元/セオリアファーマ株式会社, 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耳科用製剤
Therapeutic category codes 871329
YJ codes 1329706Q1055
Approval numbers 22900AMX00005
Package insert edition 第1版
Package insert date Jan 26, 2024
PMDA document key 380999_1329706Q1055_1
PMDA company code 380999

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)