VIZIDOR Eye drops, solution Ref.[28007] Active ingredients: Dorzolamide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Bausch and Lomb UK Ltd., Bausch & Lomb House, 106 London Road, Kingston-Upon-Thames, Surrey, KT2 6TN, UK

Product name and form

Vizidor 20 mg/ml eye drops solution.

Pharmaceutical Form

Eye drops, solution.

Clear, colourless, slightly viscous, aqueous solution with a pH between 5.0 and 6.0 and an osmolality of 270-310 mOsM/Kg.

Qualitative and quantitative composition

Each ml contains 20 mg of dorzolamide (as dorzolamide hydrochloride).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dorzolamide

Dorzolamide is a potent inhibitor of human carbonic anhydrase II. Following topical ocular administration, dorzolamide reduces elevated intra-ocular pressure, whether or not associated with glaucoma.

List of Excipients

Hydroxyethyl cellulose
Mannitol (E421)
Sodium citrate dihydrate
Sodium hydroxide (E524) (for pH adjustment)
Water for injections

Pack sizes and marketing

5 ml solution in a white opaque 11 ml LDPE bottle and white Novelia nozzle (HDPE and silicone) with a white HDPE cap.

Pack sizes: 1 or 3 bottles in cardbox.

Not all pack sizes may be marketed.

Marketing authorization holder

Bausch and Lomb UK Ltd., Bausch & Lomb House, 106 London Road, Kingston-Upon-Thames, Surrey, KT2 6TN, UK

Marketing authorization dates and numbers

PL 03468/0087

24 June 2016

Drugs

Drug Countries
VIZIDOR Estonia, Croatia, Lithuania, Poland, United Kingdom

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