PMDA drug package insert

レボフロキサシン点眼液1.5%「ニットー」

PMDA Prescription drug · 東亜薬品株式会社 · package insert May 23, 2025

Key facts

Brand names レボフロキサシン点眼液1.5%「ニットー」
Nonproprietary names レボフロキサシン水和物
Companies 製造販売元/東亜薬品株式会社, 発売元/日東メディック株式会社
Product type Prescription drug
Therapeutic category 広範囲抗菌点眼剤
Therapeutic category codes 871319
YJ codes 1319742Q2221
Approval numbers 30100AMX00154000
Package insert edition 第1版
Package insert date May 23, 2025
PMDA document key 480018_1319742Q2221_1
PMDA company code 480018

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)