PMDA drug package insert

ケトチフェン点眼液0.05%「SW」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Oct 31, 2023

Key facts

Brand names ケトチフェン点眼液0.05%「SW」
Nonproprietary names ケトチフェンフマル酸塩
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category 抗アレルギー点眼剤
Therapeutic category codes 871319
YJ codes 1319730Q1338
Approval numbers 22500AMX00922000
Package insert edition 第1版
Package insert date Oct 31, 2023
PMDA document key 300119_1319730Q1338_1
PMDA company code 300119

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)