Expert meeting on paediatric development of fixed-dose combinations for the treatment of the human immunodeficiency virus (HIV)

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TitleExpert meeting on paediatric development of fixed-dose combinations for the treatment of the human immunodeficiency virus (HIV)
Date10/11/2015 - 10/11/2015
LocationEuropean Medicines Agency, London, UK
SummaryAs a requirement of the Paediatric Regulation, all new medicinal products developed for the treatment of HIV-1 infection in adults, must have an agreed paediatric investigation plan (PIP) in place, ensuring the necessary data are obtained to support the medicine's authorisation for use in children, when appropriate. The Paediatric Committee (PDCO) is responsible for agreeing these PIPs. The purpose of this expert meeting is to advise the EMA and the PDCO on the best development pathways for fixed-dose combinations for the treatment of children and adolescents living with HIV.

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