COMBIGAN Eye drops, solution Ref.[44647] Active ingredients: Brimonidine Timolol

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, Co. Mayo, Ireland

Product name and form

Combigan 2 mg/ml + 5 mg/ml eye drops, solution.

Pharmaceutical Form
Eye drops, solution. Clear, greenish-yellow solution.

Qualitative and quantitative composition

One ml solution contains:

2.0 mg brimonidine tartrate, equivalent to 1.3 mg of brimonidine.

5.0 mg timolol as 6.8 mg timolol maleate.

Excipient(s) with known effect:

Contains benzalkonium chloride 0.05 mg/mL.

Contains phosphates 10.58 mg/mL.

Active Ingredient	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.
Timolol	Timolol is a non-selective beta-adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic activity. Timolol reduces intra-ocular pressure, whether or not this is associated with glaucoma.

List of Excipients
Benzalkonium chloride Sodium phosphate, monobasic monohydrate Sodium phosphate, dibasic heptahydrate Hydrochloric acid or sodium hydroxide to adjust pH Purified water

Pack sizes and marketing

White low density polyethylene bottles with polystyrene screw caps. Each bottle has a fill volume of 5 ml.

The following pack sizes are available: cartons containing 1 or 3 bottles of 5 ml. Not all pack sizes may be marketed.

Marketing authorization holder

Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, Co. Mayo, Ireland

Marketing authorization dates and numbers

PL 41443/0006

12^th April 2005 / 30^th March 2010

Drugs

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

Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.