VIREAD Film-coated tablet Ref.[7359] Active ingredients: Tenofovir disoproxil

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Product name and form

Viread 245 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Light blue, almond-shaped, film-coated tablets, of dimensions 16.8 mm x 10.3 mm, debossed on one side with “GILEAD” and “4331” and on the other side with “300”.

Qualitative and quantitative composition

Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate).

Excipient with known effect: Each tablet contains 156 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tenofovir disoproxil

Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination.

List of Excipients

Tablet core:

Croscarmellose sodium
Lactose monohydrate
Magnesium stearate (E572)
Microcrystalline cellulose (E460)
Starch pregelatinised

Film-coating:

Glycerol triacetate (E1518)
Hypromellose (E464)
Indigo carmine aluminium lake (E132)
Lactose monohydrate
Titanium dioxide (E171)

Pack sizes and marketing

High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.

The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Marketing authorization dates and numbers

EU/1/01/200/001
EU/1/01/200/002

Date of first authorisation: 5 February 2002
Date of latest renewal: 14 December 2011

Drugs

Drug Countries
VIREAD Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Nigeria, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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