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First Generic TDF/FTC Approved in EU

October 1, 2016

On 15 September 2016, the European Medicines Agenecy (EMA) noted a positive summary of opinion for the first generic combination of tenofovir/emtricitabine.1

The notice came from the Committee for Medicinal Products for Human Use (CHMP) who have adopted a positive opinion, recommending the granting of a marketing authorisation for tenofovir disoproxil Zentiva/emtricitabine, produced by the Czech-based generic company Zentiva, which has been owned by Sanofi-Aventis since 2008.2

Zentiva will be available as 200 mg/245 mg film-coated tablets.

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Emtricitabine/tenofovir disoproxil Zentiva is a generic version of Truvada which has been authorised in the EU since 21 February 2005. Studies have demonstrated bioequivalence to the reference product Truvada.

The full indication is: "Emtricitabine/tenofovir disoproxil Zentiva is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults".

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of opinion are usually formally approved by the EU within two months.


Comment

The implications for use of this combined generic in the UK are unclear, but when available this would enable use as treatment and PrEP.

Zentiva did not reply to an email asking about proposed marketing in the UK and related pricing.


References

  1. EMA Committee for Medicinal Products for Human Use (CHMP). Emtricitabine/tenofovir disoproxil Zentiva, Summary of opinion (initial authorisation). EMA/CHMP/596525/2016. (15 September 2016).
    www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004137/WC500212887.pdf
  2. Sanofi, Zentiva in $2.6B buyout. (22 September 2008).
    www.fiercepharma.com/pharma/sanofi-zentiva-2-6b-buyout
    www.sanofi.co.za/l/za/en/layout.jsp?scat=DD324295-1B29-40E8-B280-7A2EB627CB94



This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.
 

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