BETAGAN Eye drops, solution Ref.[9460] Active ingredients: Levobunolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Allergan Limited, Marlow International, The Parkway, Marlow, Buckinghamshire, SL7 1YL, United Kingdom

Product name and form

Betagan Unit Dose.

Pharmaceutical Form

Eye Drops, solution.

A clear, colourless to brown solution.

Qualitative and quantitative composition

One ml solution contains 5.0 mg levobunolol hydrochloride, equivalent to 4.4 mg levobunolol.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Levobunolol

Levobunolol is a non-cardioselective beta-adrenoceptor blocking agent, equipotent at both beta1 and beta2 receptors. The primary mechanism of action of levobunolol in reducing intraocular pressure is most likely a decrease in aqueous humor production. Levobunolol reduces intraocular pressure with little or no effect on pupil size in contrast to the miosis which cholinergic agents are known to produce.

List of Excipients

Poly(vinyl alcohol)
Sodium chloride
Disodium edetate
Sodium phosphate dibasic, heptahydrate
Potassium phosphate monobasic
Sodium hydroxide (to adjust pH) or hydrochloric acid (to adjust pH)
Purified water

Pack sizes and marketing

Low density polyethylene (LDPE) blow-fill-seal unit dose container (0.9 ml volume) filled with 0.4 ml solution.

Unit dose containers are packaged into a foil covered pouch (2 strips of 5 containers per pouch).

Pouches are packaged into cartons such that each carton contains 30 or 60 unit dose containers.

Marketing authorization holder

Allergan Limited, Marlow International, The Parkway, Marlow, Buckinghamshire, SL7 1YL, United Kingdom

Marketing authorization dates and numbers

PL 00426/0072

20th April 1993 / 26th July 2003

Drugs

Drug Countries
BETAGAN Brazil, France, Ireland, New Zealand, United Kingdom, United States

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