16 December 2016 - ViiV Healthcare today announced that the CHMP has adopted a positive opinion on the Type II variation and extension applications to reduce the weight and age limit for the treatment of HIV in children and adolescents with Tivicay (dolutegravir) from at least 40 kg to at least 15 kg, in ages six to less than 12 years old, and to register new dose strengths of 10 mg and 25 mg oral tablets.

Following today’s positive opinion and a subsequent final amendment of the marketing authorisation by the EMA, more children and adolescents will be eligible to receive dolutegravir in the 28 European Union member states, plus Iceland, Norway and Liechtenstein. The variation indicates the recommended dose for children from six to less than 12 years of age is to be determined according to the weight of the child, ranging from a 20mg once-daily dose for children weighing between 15kg and 20kg to a 50mg once-daily dose for children weighing 40kg or greater. This weight band-determined dosing reflects the World Health Organization (WHO) guidelines on antiretroviral therapy for HIV infection in infants and children.

Read ViiV press release