PMDA drug package insert

ケトチフェン点鼻液0.05%「ツルハラ」

PMDA Prescription drug · 鶴原製薬株式会社 · package insert Jan 9, 2024

Key facts

Brand names ケトチフェン点鼻液0.05%「ツルハラ」
Nonproprietary names ケトチフェンフマル酸塩
Companies 製造販売元/鶴原製薬株式会社
Product type Prescription drug
Therapeutic category アレルギー性鼻炎治療剤
Therapeutic category codes 871329
YJ codes 1329705Q1352
Approval numbers 30200AMX00008000
Package insert edition 第1版
Package insert date Jan 9, 2024
PMDA document key 460028_1329705Q1352_1
PMDA company code 460028

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)