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SMC ID Date Medicine Submission Type Indication
1290/18 15/01/2018 darunavir/cobicistat/emtricitabine/tenofovir alafenamide fumarate (Symtuza) Abbreviated The treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40kg).
1081/15 10/08/2015 darunavir cobicistat (Rezolsta) Full In combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older. Genotypic testing should guide its use.
1069/15 13/07/2015 darunavir (Prezista) Abbreviated Once daily darunavir co-administered with low dose ritonavir in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in paediatric patients aged 3 to 12 years and ≥15kg who are 1) treatment-naive or 2) treatment-experienced with no darunavir resistance-associated mutations, plasma-HIV-1 RNA <100,000 copies/mL, and CD4+ count >100x106 cells/L.
948/14 10/03/2014 darunavir (Prezista) Abbreviated Darunavir co-administered with low dose ritonavir in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in paediatric patients 12 to 17 years of age and at least 40kg body weight who are: antiretroviral therapy (ART) naïve; or, ART-experienced with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count ≥100 cells/mm3.
861/13 08/04/2013 darunavir (Prezista) Abbreviated Human immunodeficiency virus (HIV-1) infection in adult patients as well as antiretroviral therapy (ART)-experienced paediatric patients from the age of 3 years and at least 15 kg body weight.
707/11 08/08/2011 darunavir (Prezista) Full For the treatment of HIV-1 infection in antiretroviral therapy (ART) experienced adults
604/10 08/02/2010 darunavir (Prezista) Abbreviated HIV in children and adolescents
566/09 07/09/2009 darunavir (Prezista) Full Human immunodeficiency virus (HIV 1) infection in antiretroviral therapy (ART) naïve adults.
530/09 10/08/2009 etravirine (Intelence) Resubmission HIV-1
378/07 11/06/2007 darunavir 300mg tablets (Prezista) Full Human immunodeficiency virus (HIV-1) infection

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