ZIAGEN Film-coated tablet Ref.[6044] Active ingredients: Abacavir

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: VViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Product name and form

Ziagen 300 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablets).

The scored tablets are yellow, biconvex, capsule shaped and are engraved with ‘GX 623’ on both sides.

The tablet can be divided into equal halves.

Qualitative and quantitative composition

Each film-coated tablet contains 300 mg of abacavir (as sulfate).

For the full list of excipients see section 6.1.

Active Ingredient Description
Abacavir

Abacavir is a NRTI. It is a potent selective inhibitor of HIV-1 and HIV-2. Abacavir is metabolised intracellularly to the active moiety, carbovir 5'-triphosphate (TP). In vitro studies have demonstrated that its mechanism of action in relation to HIV is inhibition of the HIV reverse transcriptase enzyme, an event which results in chain termination and interruption of the viral replication cycle.
List of Excipients

Tablet Core:

Microcrystalline cellulose
Sodium starch glycollate
Magnesium stearate
Colloidal anhydrous silica

Tablet Coating:

Triacetin
Methylhydroxypropylcellulose
Titanium dioxide
Polysorbate 80
Iron oxide yellow

Pack sizes and marketing

Child-resistant foil blister packs (polyvinyl chloride/aluminium/paper) containing 60 tablets.

Marketing authorization holder

VViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Marketing authorization dates and numbers

EU/1/99/112/001

Date of first authorisation: 8 July 1999
Date of latest renewal: 21 March 2014

Drugs

Drug Countries
ZIAGEN Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa
 
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