EU approval for raltegravir in children aged 2 years and older
On 18 April 2013, MSD announced today that the European Commission (EC) has granted marketing authorisation to raltegravir (Isentress) for use in children two years of age and older weighing at least 12 kg.
This includes a chewable formulation (25mg and 100mg).
The new paediatric indication is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of raltegravir through 48 weeks in a multi-centre, open-label study in HIV-1 infected treatment-experienced children and adolescents two through 18 years of age (IMPAACT P1066).
For full details please see the updated Summary of Product Characteristics.
MSD press statement. MSD receives EU approval for Isentress (raltegravir) for combination use in children two years of age and older with HIV-1: chewable tablet for treating HIV-1 for paediatric patients age 2-11 years granted authorisation by the European Commission. (18 April 2013).