Basic Information
Edurant
Regulatory Information
EMEA/H/C/002264
November 28, 2011
22
October 23, 2024
Company Information
Belgium
Turnhoutseweg 30 BE-2340 Beerse
Janssen-Cilag International NV
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in paediatric patients 2 to less than 18 years of age and weighing at least 14 kg to less than 25 kg without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, and with a viral load ≤ 100,000 HIV 1 RNA copies/ml (see sections 4.4 and 5.1). Genotypic resistance testing should guide the use of EDURANT (see sections 4.4 and 5.1). EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults and paediatric patients weighing at least 25 kg without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, and with a viral load ≤ 100,000 HIV 1 RNA copies/ml (see sections 4.4 and 5.1). Genotypic resistance testing should guide the use of EDURANT (see sections 4.4 and 5.1).
Overview Summary
Edurant is an HIV medicine belonging to the class called non-nucleoside reverse transcriptase inhibitors (NNRTI). It is used in combination with other HIV medicines to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and children from 2 years of age and weighing at least 14 kg. HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS). Edurant is only used in people who have an infection with HIV-1 that has no mutations known to cause resistance to NNRTI medicines and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml. Edurant contains the active substance rilpivirine.