Reason for request

Extension of indication

-


Clinical Benefit

Substantial

The actual benefit of REYATAZ, co-administered with a low dose of ritonavir and in combination with other antiretroviral preparations, is substantial in the treatment of HIV-1 infection in adolescents and children aged 6 years and above.


Clinical Added Value

no clinical added value
REYATAZ, co-administered with a low dose of ritonavir and in combination with other antiretroviral preparations, does not provide any improvement in actual benefit (level V, non-existent) compared with available alternatives in children aged 6 years and above and in adolescents.