WELLVONE Oral suspension Ref.[6327] Active ingredients: Atovaquone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, GSK Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK

Product name and form

Wellvone 750 mg/5 ml oral suspension.

Pharmaceutical Form

Oral suspension.

Wellvone oral suspension is a bright yellow liquid.

Qualitative and quantitative composition

Each 5 ml of oral suspension contains 750 mg atovaquone.

Excipient with known effect: Each 5 ml of oral suspension contains 50.66 mg benzyl alcohol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Atovaquone

Atovaquone is a selective and potent inhibitor of the eukaryotic mitochondrial electron transport chain in a number of parasitic protozoa and the parasitic fungus P. jiroveci. The site of action appears to be the cytochrome bc1 complex (complex III).

List of Excipients

Benzyl alcohol
Xanthan Gum
Poloxamer 188
Saccharin Sodium
Purified water
Tutti Frutti Flavour (Firmenich 51.880/A) containing sweet orange oil, concentrated orange oil, propylene glycol, benzyl alcohol, vanillin, acetic aldehyde, amyl acetate and ethyl butyrate.

Pack sizes and marketing

A 240 ml high density polyethylene bottle with child resistant polypropylene closure, containing 226 ml of atovaquone suspension.

A double ended measuring spoon (polypropylene) is included, however, only 5 ml end (larger end) of the measuring spoon must be used.

Marketing authorization holder

Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, GSK Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK

Marketing authorization dates and numbers

PL 10949/0271

Date of first authorisation: 25 March 1997
Date of latest renewal: 21 May 2006

Drugs

Drug Countries
WELLVONE Australia, Estonia, Spain, France, Netherlands, United Kingdom, South Africa

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