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EU grants Marketing Authorisation to first-ever dispersible-tablet dolutegravir

January, 2021

On 12 January 2021, the European Medicine Agency approved the use of dolutegravir 5mg dispersible tablets for treating HIV in young children living in Europe.

ODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing

Authors: Moore CL, Turkova A, Mujuru H, Kekitiinwa A, Lugemwa A, Kityo CM, Barlow-Mosha LN, Cressey TR, Violari A, Variava E, Cotton MF, Archary M, Compagnucci A, Puthanakit T, Behuhuma O, Saϊdi Y, Hakim J, Amuge P, Atwine L, Musiime V, Burger DM, Shakeshaft C,...

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