CHMP positive recommendation to change to marketing authorisation of Triumeq (abacavir sulfate / dolutegravir sodium / lamivudine) to treat HIV infections.-ViiV HealthCare
On 25 April 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Triumeq.
The marketing authorisation holder for this medicinal product is ViiV Healthcare B.V.
The CHMP adopted an extension to the existing indication for Triumeq (abacavir sulfate / dolutegravir sodium / lamivudine) dispersable tablets to include children from 3 months of age and weighing at least 6 kg.
Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
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