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21

Jan, 2021

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

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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. This decision was based, in part, on data from our ODYSSEY trial, which we are conducting in close collaboration with the MRC CTU at the University College London. The EMA also authorised updating dosing recommendations for dolutegravir film-coated tablets (10mg, 25mg and 50mg) for children six years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands. […]

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19

Nov, 2020

European Medicines Agency approves use of Dolutegravir 5 mg dispersible tablet for younger children living with HIV

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On November 12th, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending marketing authorisation for dolutegravir 5mg dispersible tablets for young children living with HIV. This decision was based, in part, on data from the ODYSSEY trial. These small tablets can now be used in combination with other medicines for treating children living with HIV who are aged at least four weeks and weigh at least 3kg. CHMP’s positive opinion also supported the updated dosing recommendations for dolutegravir film-coated […]

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