Nirmatrelvir / ritonavir Medicine 04 December 2025 Extended indication Extension of indication to include treatment of coronavirus disease 2019 (COVID -19) in paediatric patients 6 years of age and older weighing at least 20kg Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Nirmatrelvir / ritonavir Domain Infectious diseases Reason of inclusion Indication extension IND Main indication COVID-19 Extended indication Extension of indication to include treatment of coronavirus disease 2019 (COVID -19) in paediatric patients 6 years of age and older weighing at least 20kg Current proprietary name Already available biosimilars / generics Proprietary name Paxlovid Manufacturer Pfizer Portfolio holder Mechanism of action Proteasome 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 Normal trajectory Particularity Unknown ATMP No Submission date January 2025 Expected Registration December 2025 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in oktober 2025. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT05261139 (EPIC-Peds) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks De inzet blijft zeer beperkt zolang er geen tot weinig COVID-19 is. Expected cost per patient per year Cost References Taxe november 2025 Additional remarks De apotheek inkoopprijs is €1.047,70 (exclusief BTW) per verpakking van 30 (20+10) tabletten. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks