TELZIR Film-coated tablet Ref.[8776] Active ingredients: Fosamprenavir

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands

Product name and form

Telzir 700 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Pink film coated, capsule shaped, biconvex tablets, marked with GXLL7 on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fosamprenavir

Fosamprenavir after oral administration, is rapidly and almost completely hydrolysed to amprenavir and inorganic phosphate prior to reaching the systemic circulation. Amprenavir binds to the active site of HIV-1 protease and thereby prevents the processing of viral gag and gag-pol polyprotein precursors, resulting in the formation of immature noninfectious viral particles.

List of Excipients

Tablet core:

Microcrystalline cellulose
Croscarmellose sodium
Povidone K30
Magnesium stearate
Colloidal anhydrous silica

Tablet film-coat:

Hypromellose
Titanium dioxide (E171)
Glycerol triacetate
Iron oxide red (E172)

Pack sizes and marketing

HDPE bottles with a child resistant polypropylene closure containing 60 tablets.

Marketing authorization holder

ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands

Marketing authorization dates and numbers

EU/1/04/282/001

Date of first authorisation: 12 July 2004
Date of renewal of authorisation: 15 May 2009

Drugs

Drug Countries
TELZIR Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, South Africa

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