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.
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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.
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