Atazanavir / cobicistat

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.
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 other
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 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	No judgement

There is currently nothing known about the expected patient volume.

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

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.