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Edurant (rilpivirine)

Region

🇪🇺 EU

Active substance

rilpivirine

Status

Authorised

Therapeutic area

HIV Infections

EU approval

Mon 28 Nov 2011

Application

EMEA/H/C/002264

ATC

J05AG05

Official record

www.ema.europa.eu

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).

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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• 🇪🇺 Juluca Authorised · ViiV Healthcare B.V.
• 🇪🇺 Rekambys Authorised · Janssen-Cilag International NV
• 🇪🇺 Odefsey Authorised · Gilead Sciences Ireland UC

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.