Dolutegravir / Lamivudine Medicine 04 June 2026 Extended indication Extension application to include treatment of children weighing at least 20 kg for Dovato. Therapeutic value Total cost Registration phase Registration application pending Product Active substance Dolutegravir / Lamivudine Domain Infectious diseases Reason of inclusion Indication extension IND Main indication HIV Extended indication Extension application to include treatment of children weighing at least 20 kg for Dovato. Current proprietary name Already available biosimilars / generics Proprietary name Dovato Manufacturer ViiV Portfolio holder ViiV Mechanism of action HIV inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity New therapeutical formulation ATMP Submission date March 2026 Expected Registration February 2027 Orphan drug Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration 5 mg/30 mg References Additional remarks new strength (5 mg/30 mg) Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks