MHRA-100303-PIP01-21-M03 (update)

Key Facts

Active Substance
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • COBICISTAT
  • DARUNAVIR ETHANOLATE
Invented Name
  • Symtuza
  • Symtuza
  • Symtuza
  • Symtuza
PIP Number MHRA-100303-PIP01-21-M03 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of human immunodeficiency virus type-1 (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
28/01/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100303-PIP01-21-M03-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):EMTRICITABINETENOFOVIR ALAFENAMIDE FUMARATECOBICISTATDARUNAVIR ETHANOLATE.pdf
Published Date 10/03/2025