Posted by Michael Wonder on 14 Jan 2021
ViiV Healthcare receives EU marketing authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe
13 January 2021 - Dolutegravir is the first integrase inhibitor available as a dispersible tablet for children weighing at least 3kg and from four weeks of age.
ViiV Healthcare today announced that the European Commission has granted Marketing Authorisation for Tivicay (dolutegravir) 5 mg dispersible tablets, which are used in combination with other anti-retroviral agents for the treatment of human immunodeficiency virus type 1 infection in paediatric patients (treatment-naïve or experienced but INSTI-naïve) aged at least four weeks and weighing at least 3 kg.
This authorisation includes updated dosing recommendations, for Tivicay (dolutegravir) film-coated tablets (10 mg, 25 mg and 50 mg) for children 6 years and older and weighing at least 14 kg, bringing these in line with the World Health Organization weight bands.
