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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.