MHRA-100669-PIP01-22-M01 (update)

Key Facts

Active Substance
  • EMTRICITABINE
  • RILPIVIRINE
  • TENOFOVIR ALAFENAMIDE FUMARATE
Invented Name
  • Odefsey
  • Odefsey
  • Odefsey
  • Odefsey
PIP Number MHRA-100669-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet Age-appropriate oral formulation
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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):EMTRICITABINERILPIVIRINETENOFOVIR ALAFENAMIDE FUMARATE.pdf
Published Date 25/05/2023