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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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