EPARs human use - Sustiva//Efavirenz

FICHA FARMACOLÓGICA de Efavirenz. Contiene la Monografía en distintos idiomas (de la Comunidad Económica 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 24, 2009.-

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EPARs for authorised medicinal products for human use - Sustiva

Active Substance
Efavirenz
International Nonproprietary Name or Common Name
Efavirenz
Pharmaco-therapeutic Group
Non-nucleoside reverse transcriptase inhibitors
ATC Code
JO5A G03

Therapeutic Indication:
SUSTIVA is indicated in antiviral combination treatment of HIV-1 infected adults, adolescents and children 3 years of age and older.

SUSTIVA has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI) containing regimens. Although cross-resistance of efavirenz with protease inhibitors has not been documented, there are at present insufficient data on the efficacy of subsequent use of protease inhibitor based combination therapy after failure of regimens containing SUSTIVA.

See 5.1 Pharmacodynamic properties: Pharmacodynamic effects for a summary of clinical and pharmacodynamic information.

Date of issue of Marketing Authorisation valid throughout the European Union
28 May 1999

Orphan medicinal product designation date
Not applicable