ALPHAGAN Eye drops, solution Ref.[6615] Active ingredients: Brimonidine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: AbbVie Ltd., Maidenhead, SL6 4UB, UK

Product name and form

Alphagan 0.2% w/v (2 mg/ml) eye drops, solution.

Pharmaceutical Form

Eye drops, solution.

Clear, greenish-yellow to light greenish-yellow solution.

Qualitative and quantitative composition

One ml solution contains 2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine.

Excipient with known effect: Contains benzalkonium chloride 0.05 mg/ml.

For the full list of excipients, see section 6.1.

Active Ingredient

Brimonidine is an alpha2-adrenergic receptor agonist that is 1000-fold more selective for the alpha2-adrenoceptor than the alpha1-adrenoreceptor. This selectivity results in no mydriasis and the absence of vasoconstriction in microvessels associated with human retinal xenografts.
List of Excipients

Benzalkonium chloride
Poly(vinyl alcohol)
Sodium chloride
Sodium citrate
Citric acid monohydrate
Purified water
Hydrochloric acid (for pH-adjustment) or
Sodium hydroxide (for pH-adjustment)

Pack sizes and marketing

White low density polyethylene dropper bottles with a 35 microlitre tip. The cap is either a conventional polystyrene screw cap or a Compliance Cap (C-Cap).

2.5 ml, 5 ml and 10 ml bottles in packs of 1, 3 or 6. Not all pack sizes may be marketed.

Marketing authorization holder

AbbVie Ltd., Maidenhead, SL6 4UB, UK

Marketing authorization dates and numbers

PL 41042/0052

Date of first authorisation: 18 March 1997
Date of last renewal: 17 September 2006

Drugs

Drug Countries
ALPHAGAN Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Malta, Mexico, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa
 
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