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.
|
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
2CYfAq6BhT7mXDGy