🇪🇺 Tenofovir Film in European Union

EMA authorised Tenofovir Film on 15 September 2016

Marketing authorisations

Application: EMEA/H/C/004120
Marketing authorisation holder: Zentiva k.s.
Local brand name: Tenofovir disoproxil Zentiva
Indication: HIV?1 infection Tenofovir disoproxil Zentiva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV?1 infected adults. In adults, the demonstration of the benefit of tenofovir disoproxil in HIV?1 infection is based on results of one study in treatment?naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre?treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority o
Status: approved

Application: EMEA/H/C/004049
Marketing authorisation holder: Viatris Limited
Local brand name: Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan)
Indication: HIV-1 infection Tenofovir disoproxil 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults. In adults, the demonstration of the benefit of tenofovir disoproxil in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml,
Status: approved

Is Tenofovir Film approved in European Union?

Yes. EMA authorised it on 15 September 2016; EMA authorised it on 8 December 2016.

Who is the marketing authorisation holder for Tenofovir Film in European Union?

Zentiva k.s. holds the EU marketing authorisation.