Darunavir Mylan
darunavir
HIV Infections
Date of authorisation:
Revision: 14
Last updated:
MedicineHumanAuthorised
EMEA-001825-PIP01-15-M04 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: P/0029/2023
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001280-PIP01-12-M05 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: P/0039/2023
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Dispersible tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Rezolsta
darunavir
cobicistat
HIV Infections
Date of authorisation:
Revision: 16
Last updated:
MedicineHumanAuthorised
Darunavir Krka
darunavir
HIV Infections
Date of authorisation:
Revision: 10
Last updated:
MedicineHumanAuthorised
Symtuza
darunavir
cobicistat
emtricitabine
tenofovir alafenamide
HIV Infections
Date of authorisation:
Revision: 17
Last updated:
MedicineHumanAuthorised
Prezista
darunavir
HIV Infections
Date of authorisation:
Revision: 54
Last updated:
MedicineHumanAuthorised
Darunavir Krka d.d.
darunavir
HIV Infections
Date of authorisation:
Revision: 8
Last updated:
MedicineHumanExpired
EMEA-002537-PIP02-19 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: P/0308/2020
Route(s) of administration: Oral use
Pharmaceutical form(s):
Film-coated tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman