EMA extends indication for darunavir/r to include adolescents >12 years

28 August 2020. Related: Antiretrovirals.

EMA monthly review

On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) recommended extending the indication for daruavir/r to adolescents age 12 and older who weigh >40 kg.

For full details please see the updated summary of product characteristics.

Darunavir/r is marketed by Janssen-Cilag with the trade name Prezista.

Reference

EMA. Prezista.
https://www.ema.europa.eu/en/medicines/human/summaries-opinion/prezista

This article was originally posted on 25 August 2020.