ViiV Healthcare welcomes European Commission approval of dolutegravir paediatric Type II variation and extension applications

ViiV

28 February 2017 - ViiV Healthcare has today announced that the European Commission has approved 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.

This approval follows the CHMP positive opinion in December 2016 and the U.S. FDA paediatric approval, in June 2016, of dolutegravir for a reduced age and weight limit.

Read ViiV press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe , Paediatrics