MHRA-100669-PIP01-22-M02 (update)

Key Facts

Active Substance
  • RILPIVIRINE
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
Invented Name
  • Odefsey
  • Odefsey
  • Odefsey
PIP Number MHRA-100669-PIP01-22-M02 (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 (HIV-1) infection
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
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):RILPIVIRINEEMTRICITABINETENOFOVIR ALAFENAMIDE.pdf
Published Date 30/01/2024