MOXIVIG Eye drops Ref.[7001] Active ingredients: Moxifloxacin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland.

Product name and form

MOXIVIG 0.5% w/v eye drops, solution.

Pharmaceutical Form

Eye drops (solution).

Clear, greenish-yellow solution.

Qualitative and quantitative composition

1 ml of solution contains 5.45 mg moxifloxacin hydrochloride (equivalent to 5 mg moxifloxacin).

Each eye drop contains 190 micrograms of moxifloxacin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Moxifloxacin

Moxifloxacin, a fourth-generation fluoroquinolone, has in vitro activity against a wide range of Gram-positive and Gram-negative pathogens. The bactericidal action of moxifloxacin results from the inhibition of both type II topoisomerases (DNA gyrase and topoisomerase IV) required for bacterial DNA replication, transcription and repair.

List of Excipients

Sodium chloride
Boric acid
Hydrochloric acid and/or sodium hydroxide (to adjust pH)
Purified water

Pack sizes and marketing

5 ml bottle with DROP-TAINER dispensing system consisting of a transparent low density polyethylene bottle and dispensing plug and white polypropylene closure. Tamper evidence is provided by a security seal around the closure of the bottle.

Pack size: box containing 1 bottle.

Marketing authorization holder

Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland.

Marketing authorization dates and numbers

PL 23860/0016

Date of first authorisation: 27/07/2009
Date of last renewal: 29/04/2014

Drugs

Drug Countries
MOXIVIG United Kingdom

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