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.
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.
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.
No comments have been made.
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