Extended indication Extension of indication to include the use of EVOTAZ in combination with other antiretroviral agents
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Atazanavir / cobicistat
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Viral infections
Extended indication Extension of indication to include the use of EVOTAZ in combination with other antiretroviral agents in the treatment of HIV-1 infection in adolescent patients aged ≥ 12 to < 18 years, weighing ≥ 35 kg without known mutations associated with resistance to atazanavir.
Proprietary name Evotaz
Manufacturer BMS
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date September 2020
Expected Registration July 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Additional comments Atazanavir en cobicistat kosten los: REYATAZ, CAPSULE 150MG 0,3 g €15,02. TYBOST, TABLET 150MG 0,15 g € 1,09.

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.