VOXRA Extended-release tablet Ref.[115265] Active ingredients: Bupropion

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2024  Publisher: GlaxoSmithKline South Africa (Pty) Ltd, 39 Hawkins Avenue, Epping Industria 1, 7460

Product name and form

VOXRA XL 150 mg extended-release tablets.

VOXRA XL 300 mg extended-release tablets.

Pharmaceutical Form

Extended-release tablets.

VOXRA XL 150: Creamy white to pale yellow, round tablet, imprinted with 'GS 5FV 150' in black ink on one side and the other side plain.

VOXRA XL 300: Creamy white to pale yellow, round tablet, imprinted with 'GS 5YZ 300' in black ink on one side and the other side plain.

Qualitative and quantitative composition

Each VOXRA XL 150 tablet contains 150 mg of bupropion hydrochloride.

Each VOXRA XL 300 tablet contains 300 mg of bupropion hydrochloride.

Sugar-free.

For full list of excipients, see section 6.1.

Active Ingredient

Bupropion is a selective inhibitor of the neuronal re-uptake of catecholamines (noradrenaline and dopamine) with minimal effect on the re-uptake of indolamines (serotonin) and does not inhibit either monoamine oxidase. The mechanism by which bupropion enhances the ability of patients to abstain from smoking is unknown. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms.
List of Excipients

Tablet core:

Polyvinyl alcohol
Glyceryl behenate

Film-coat:

Ethylcellulose 100
Povidone
Polyethylene glycol 1450
Methacrylic acid copolymer dispersion (Eudragit L30 D-55)
Silicon dioxide
Triethyl citrate
Edible black ink (containing Shellac glaze, isopropyl alcohol, Iron Oxide black (E172), n-butyl alcohol, propylene glycol and ammonium hydroxide).

Pack sizes and marketing

VOXRA XL 150: White opaque plastic HDPE bottles with white polypropylene plastic child-resistance closures, containing 30 tablets.

VOXRA XL 300: White opaque plastic HDPE bottles with white polypropylene plastic child-resistance closures, containing 30 tablets.

Marketing authorization holder

GlaxoSmithKline South Africa (Pty) Ltd, 39 Hawkins Avenue, Epping Industria 1, 7460

Marketing authorization dates and numbers

VOXRA XL 150: 41/1.2/0373
VOXRA XL 300: 41/1.2/0374

17 April 2009

Drugs

Drug Countries
VOXRA Finland, South Africa
 
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