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EU gives extended approval for formulation of Tivicay for paediatric patients with HIV.- ViiV Healthcare

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Published:15th Jan 2021
ViiV Healthcare has been given EU marketing authorisation for a dispersible tablet formulation of Tivicay (dolutegravir) in paediatric HIV-1 patients aged at least four weeks and weighing at least 3kg. This approval is the first for a dispersible tablet for children in this category. This EU approval is based on results from the ongoing P1093 and ODYSSEY studies. Last year the FDA also approved this dispersible tablet formulation for the treatment of HIV-1 infection in the same paediatric group.
Condition: HIV/AIDS
Type: drug

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