MHRA-100865-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • RILPIVIRINE
Invented Name
REKAMBYS
PIP Number MHRA-100865-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Prolonged-release suspension for injection
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:
  • Intramuscular 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
08/12/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100865-PIP01-23-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):RILPIVIRINE.pdf
Published Date 19/12/2023