MHRA-100845-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • CABOTEGRAVIR
Invented Name
  • VOCABRIA and CABENUVA
  • Apretude
  • APRETUDE
  • Apretude
  • VOCABRIA/APRETUDE
PIP Number MHRA-100845-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Prolonged-release suspension for injection
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Prevention of human immunodeficiency virus (HIV-1) infection
Route(s) of administration
  • Intramuscular use
  • ORAL USE
PIP applicant
  • ViiV Healthcare UK Limited
  • Country United Kingdom
  • Tel 02080475000
  • Email oax52639@gsk.com
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):CABOTEGRAVIR.pdf
Published Date 20/06/2023