Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 09 August 2018

Indication(s)

Emtriva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults and children aged 4 months and over.
 
This indication is based on studies in treatment-naïve patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens.
 
When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.

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More information

Category Value
Agency product number EMEA/H/C/000533
Orphan designation No
Date First Approved 24-10-2003
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Gilead Sciences Ireland UC