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WELLVONE Oral suspension (2019)

Active ingredients: Atovaquone

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 ml of suspension contains 150 mg atovaquone.

A unit dose of 5 ml contains 750 mg atovaquone.

For the full list of excipients, see section 6.1.

Chemical substance
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 5 ml measuring spoon (polypropylene) is included.

Marketing authorization holder
Authorization dates

Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS

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

Marketing authorization number:

PL 10949/0271