Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Opatanol 1 mg/mL eye drops, solution.
| Pharmaceutical Form |
|---|
|
Eye drops, solution (eye drops). Clear, colourless solution. |
One mL of solution contains 1 mg olopatadine (as hydrochloride).
Excipient(s) with known effect:
Benzalkonium chloride 0.1 mg/ml.
Disodium phosphate dodecahydrate (E339) 12.61 mg/ml (equivalent to 3.34 mg/ml of phosphates).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Olopatadine |
Olopatadine is a potent selective antiallergic/antihistaminic agent that exerts its effects through multiple distinct mechanisms of action. |
| List of Excipients |
|---|
|
Benzalkonium chloride |
5 ml opaque low density polyethylene bottles with polypropylene screw caps.
Cartons containing 1 or 3 bottles. Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/02/217/001-002
Date of first authorisation: 17 May 2002
Date of latest renewal: 22 May 2007
| Drug | Countries | |
|---|---|---|
| OPATANOL | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Nigeria, Netherlands, Poland, Romania, Tunisia, United Kingdom |
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