Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EMADINE 0.5 mg/ml, eye drops, solution.
| Pharmaceutical Form |
|---|
|
Eye drops, solution. Clear, colourless solution. |
1 ml of solution contains emedastine 0.5 mg (as difumarate).
Excipient with known effect: Benzalkonium chloride 0.1 mg/ml.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Emadine |
Emedastine is a potent selective and topically effective histamine H1 antagonist. In vivo topical ocular administration of emedastine produces a concentration-dependent inhibition of histamine-stimulated conjunctival vascular permeability. |
| List of Excipients |
|---|
|
Benzalkonium chloride 0.1 mg/ml |
EMADINE is supplied in 5 ml and 10 ml opaque plastic DROP-TAINER bottles.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/98/095/001-2
Date of first authorisation: 27 January 1999
Date of latest renewal: 13 January 2009
| Drug | Countries | |
|---|---|---|
| EMADINE | Austria, Cyprus, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Lithuania, Netherlands, Poland, Singapore, Tunisia, Turkey, United States, South Africa |
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