MHRA-100300-PIP01-21-M03 (update)

Key Facts

Active Substance
  • DARUNAVIR
  • COBICISTAT
Invented Name
Not yet available
PIP Number MHRA-100300-PIP01-21-M03 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Dispersible tablet
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of human immunodeficiency virus (HIV-1) infection
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
02/04/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100300-PIP01-21-M03-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DARUNAVIRCOBICISTAT.pdf
Published Date 14/04/2026