Betoptic Eye Drops Solution Ref.[2555] Active ingredients: Betaxolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2012  Publisher: Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way HemelHempstead Herts. HP2 7UD

Product name and form

Betoptic 0.5% w/v eye drops, solution.

Pharmaceutical Form

Eye Drops, Solution.

Qualitative and quantitative composition

Betaxolol 0.5% w/v (as hydrochloride).

Active Ingredient

Betaxolol is a cardioselective Beta1 receptor blocker which, when applied topically to the eye, lowers intraocular pressure. It is thought to produce this effect by reducing the rate of production of aqueous humour.
List of Excipients

Disodium edetate
Sodium chloride
Benzalkonium chloride
Sodium hydroxide
Hydrochloric acid
Purified water

Pack sizes and marketing

5 ml & 10 ml LDPE bottles (10 ml present in 15 ml container) with natural LDPE plug and blue polystyrene or polypropylene cap.

Marketing authorization holder

Alcon Laboratories (UK) Ltd
Pentagon Park
Boundary Way
HemelHempstead
Herts. HP2 7UD

Marketing authorization dates and numbers

PL 0649/0097

19th August 1986 / 14th November 2001

Drugs

Drug Countries
BETOPTIC Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa
 
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