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

Key Facts

PIPS Key Facts
Active Substance
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
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):RILPIVIRINEEMTRICITABINETENOFOVIR ALAFENAMIDE.pdf
Published Date 30/01/2024