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Darunavir / Cobicistat

Rezolsta

Extended indication Darunavir/cobicistat monotherapy for treatment of HIV-1 infection in children over 6 years of age we
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Darunavir / Cobicistat
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication HIV
Extended indication Darunavir/cobicistat monotherapy for treatment of HIV-1 infection in children over 6 years of age weighing at least 25 kg.
Proprietary name Rezolsta
Manufacturer Janssen
Portfolio holder Janssen
Mechanism of action Virus inhibitor
Route of administration Oral
Therapeutical formulation Film-coated tablet
Budgetting framework Extramural (GVS)
Additional remarks Darunavir is een proteaseremmer. Cobicistat versterkt de werking van darunavir doordat het de tijd dat darunavir in het lichaam werkzaam is, verlengt.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date June 2024
Expected Registration April 2025
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
References NCT02016924
Additional remarks darunavir 675 mg/cobicistat 150 mg once daily

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 4,692.00
References G- standaard en SmPC
Additional remarks Het gaat om een nieuwe dosering en tablet. Het is wel mogelijk een inschatting te maken op huidige dosering: Rezolsta tablet filmomhuld 800/150mg 30 stk AIP €385,68 exclusief BTW. Dosering is 1 tablet per dag.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.