Expert meeting on paediatric development of fixed-dose combinations for the treatment of the human immunodeficiency virus (HIV)
Date:
10/11/2015
Location:
European Medicines Agency, London, UK
As 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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Agenda - Expert meeting on paediatric development of fix-dose combinations for treatment of HIV (PDF/70.09 KB)
Draft
First published: 29/09/2015
Last updated: 29/09/2015
EMA/589180/2015 -
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Presentation - Meeting objectives (PDF/1.18 MB)
First published: 05/01/2016
Last updated: 05/01/2016 -
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Presentation - Agreed PIPs for FDCs for the treatment of HIV-1 infection (Andrea Ecker) (PDF/116.44 KB)
First published: 05/01/2016
Last updated: 05/01/2016 -
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Presentation - HIV and FDC: aspects of two guidelines (Filip Josephson) (PDF/394.12 KB)
First published: 05/01/2016
Last updated: 05/01/2016 -
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Report of the expert meeting on paediatric development of fixed-dose combinations (FDCs) for the treatment of human immunodeficiency virus (HIV) infection (PDF/119.38 KB)
First published: 02/02/2016
Last updated: 02/02/2016
EMA/766040/2015