PMDA drug package insert

カルテオロール塩酸塩点眼液1%「ニットー」

PMDA Prescription drug · 東亜薬品株式会社 · package insert Jun 26, 2026

Key facts

Brand names カルテオロール塩酸塩点眼液1%「ニットー」, カルテオロール塩酸塩点眼液2%「ニットー」
Nonproprietary names カルテオロール塩酸塩
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 緑内障・高眼圧症治療剤
Therapeutic category codes 871319
YJ codes 1319701Q1129, 1319701Q2125
Approval numbers 23100AMX00031000, 23100AMX00032000
Package insert edition 第1版
Package insert date Jun 26, 2026
PMDA document key 480018_1319701Q1129_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)