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ZIAGEN Film-coated tablet (2018)

Active ingredients: Abacavir

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.

Chemical substance
Description
Abacavir

Abacavir is a potent selective inhibitor of HIV-1 and HIV-2. The mechanism of action as to HIV, is the inhibition of the enzyme reverse transcriptase of HIV, an event that causes chain termination and stopping the replication cycle of the virus.

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
Authorization dates

ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Date of first authorisation: 8 July 1999

Date of latest renewal: 21 March 2014

Marketing authorization number:

EU/1/99/112/001