🇪🇺 Tenofovir (TDF) in European Union

EMA authorised Tenofovir (TDF) on 4 February 2002

Marketing authorisation

EMA — authorised 4 February 2002

  • Application: EMEA/H/C/000419
  • Marketing authorisation holder: Gilead Sciences Ireland UC
  • Local brand name: Viread
  • Indication: HIV 1 infection Viread 123 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 17 kg to less than 22 kg. The choice of Viread to treat antiretroviral experienced patients with HIV 1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Viread 123 mg film coated tablets are indicated for the treatment of chronic
  • Status: approved

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Frequently asked questions

Is Tenofovir (TDF) approved in European Union?

Yes. EMA authorised it on 4 February 2002.

Who is the marketing authorisation holder for Tenofovir (TDF) in European Union?

Gilead Sciences Ireland UC holds the EU marketing authorisation.