OPATANOL Eye drops, solution Ref.[8571] Active ingredients: Olopatadine

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

Opatanol 1 mg/mL eye drops, solution.

Pharmaceutical Form

Eye drops, solution (eye drops).

Clear, colourless solution.

Qualitative and quantitative composition

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
Sodium chloride
Disodium phosphate dodecahydrate (E339)
Hydrochloric acid (E507) (to adjust pH)
Sodium hydroxide (E524) (to adjust pH)
Purified water

Pack sizes and marketing

5 ml opaque low density polyethylene bottles with polypropylene screw caps.

Cartons containing 1 or 3 bottles. Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/02/217/001-002

Date of first authorisation: 17 May 2002
Date of latest renewal: 22 May 2007

Drugs

Drug Countries
OPATANOL Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Lithuania, Nigeria, Netherlands, Poland, Romania, Tunisia, United Kingdom

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