Reason for request
Inclusion for the oral suspension and Extension of the indication for 75 mg, 150 mg, 300 mg and 600 mg tablets.
Clinical Benefit
Substantial |
The Actual Benefit is substantial in the Marketing Authorisation indications.
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Clinical Added Value
moderate |
PREZISTA 100 mg/ml, oral suspension In view of the small number of alternative treatments, the Committee considers that the proprietary medicinal product PREZISTA oral solution, co-administered with a low dose of ritonavir and other antiretroviral preparations, constitutes an improvement in actual benefit (IAB III) in the treatment of human immunodeficiency virus (HIV-1) infection in ART-experienced children aged 3 to 6 years and weighing at least 15 kg. In the management of HIV-1 infection in children from the age of 6 years, previously-treated adolescents and adults The Committee considers that the proprietary medicinal product PREZISTA oral solution, co-administered with a low-dose of ritonavir and other antiretroviral agents is an addition to the range and does not therefore offer any improvement in actual benefit: IAB V (non-existent) in the treatment of human immunodeficiencyvirus in treatment-experienced children and adolescents from the age of 6 years and in adults. PREZISTA 75 mg, 150 mg, 300 mg and 600 mg, film-coated tablet In the extension of indication for the tablet forms in the previously-treated paediatric population aged from 3 to 6 years weighing between 15 and 20 kg, the Committee considers that the medicinal product PREZISTA, co- administered with a low dose of ritonavir and other antiretroviral agents, constitutes a moderate improvement in actual benefit (IAB III) in the treatment of human immunodeficiency virus (HIV-1) infection.
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