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

• Date:
  kedd, 10 november 2015, Egész nap
• Helyszín:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Agenda - Expert meeting on paediatric development of fix-dose combinations for treatment of HIV

Draft Reference Number: EMA/589180/2015

Presentation - Meeting objectives

Presentation - Agreed PIPs for FDCs for the treatment of HIV-1 infection (Andrea Ecker)

Presentation - HIV and FDC: aspects of two guidelines (Filip Josephson)

Report of the expert meeting on paediatric development of fixed-dose combinations (FDCs) for the treatment of human immunodeficiency virus (HIV) infection

Reference Number: EMA/766040/2015