ZADITEN Eye drops, solution Ref.[7795] Active ingredients: Ketotifen

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Laboratoires Thea, 12, rue Louis Blรฉriot, 63017 Clermont-Ferrand Cedex 2, France

Product name and form

Zaditen 0.25 mg/ml, eye drops, solution.

Pharmaceutical Form

Eye drops, solution.

Clear, colourless to faintly yellow solution.

Qualitative and quantitative composition

One ml contains 0.345 mg ketotifen fumarate corresponding to 0.25 mg ketotifen.

Each drop contains 8.5 microgram ketotifen fumarate.

Excipient(s) with known effect: Benzalkonium chloride (0.1 mg/ml).

For the full list of excipients, see section 6.1.

Active Ingredient Description

Ketotifen is a histamine H1-receptor antagonist. In vivo animal studies and in vitro studies suggest the additional activities of mast cell stabilisation and inhibition of infiltration, activation and degranulation of eosinophils.

List of Excipients

Benzalkonium chloride
Glycerol (E422)
Sodium hydroxide (E524)
Water for injections

Pack sizes and marketing

The container is a white-coloured LDPE bottle with a transparent LDPE dropper and a white HDPE screw cap with an integrated safety ring. One bottle contains 5 ml of the solution.

Marketing authorization holder

Laboratoires Thea, 12, rue Louis Blรฉriot, 63017 Clermont-Ferrand Cedex 2, France

Marketing authorization dates and numbers


Date of first authorisation: 24 November 2000
Date of last renewal: 30 June 2010


Drug Countries
ZADITEN Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Italy, Japan, Mexico, Nigeria, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, South Africa

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