Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Laboratoires Thea, 12, rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France
Zaditen 0.25 mg/ml, eye drops, solution.
| Pharmaceutical Form |
|---|
|
Eye drops, solution. Clear, colourless to faintly yellow solution. |
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 |
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 |
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.
Laboratoires Thea, 12, rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France
PA1107/010/001
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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