Shots:

• The approval is based on P1093 & ODYSSEY (Penta20) studies assessing safety- tolerability & dose-finding of Tivicay (5mg) in pediatric patients aged 4wks.-18yrs. while the second study assessed the 1L & 2L treatment in patients of the same age
• The approval includes updated dosing recommendations for Tivicay film-coated tablets (10/25/50mg) for children aged ≥6yrs. and weighing at least 14kg- bringing these in line with the WHO weight bands
• Dolutegravir is the first integrase inhibitor used in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least 4wks. and weighing at least 3kg.

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