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ALPHAGAN Eye drops, solution (2014)

Active ingredients: Brimonidine

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(s): Contains benzalkonium chloride 0.05 mg/ml. For a full list of excipients, see section 6.1.

Chemical substance
Description
Brimonidine

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
Authorization dates

Allergan Ltd, 1st Floor Marlow International, The Parkway, Marlow, Buckinghamshire SL7 1YL, UK

Date of first authorisation: 18 March 1997

Date of last renewal: 17 September 2006

Marketing authorization number:

PL 00426/0088