darunavir - EPARs for authorised medicinal products for human use - Prezista

FICHA FARMACOLÓGICA de darunavir . Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. JUNIO 26, 2010.-

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EPARs for authorised medicinal products for human use - Prezista

Active Substance
darunavir
International Nonproprietary Name or Common Name
darunavir
Pharmaco-therapeutic Group
Antivirals for systemic use
ATC Code
J05AE10

Therapeutic Indication:
PREZISTA, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral treatment (ART) experienced adult patients, including those that have been highly pre-treated, and for the treatment of HIV-1 infection in ART-experienced children and adolescents from the age of 6 years and at least 20 kg body weight.



In deciding to initiate treatment with PREZISTA co-administered with low dose ritonavir careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.,



PREZISTA 400 mg, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral therapy (ART) naïve adults.


Date of issue of Marketing Authorisation valid throughout the European Union
12 February 2007

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use