MHRA-100845-PIP01-23-M02 (update)

Key Facts

Active Substance
Active Substance:
  • CABOTEGRAVIR
Invented Name
  • N/A
  • VOCABRIA AND APRETUDE
  • Apretude
  • N/A
  • N/A
  • N/A
  • Apretude
  • Apretude
PIP Number MHRA-100845-PIP01-23-M02 (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
  • Oral use
  • INTRAMUSCULAR 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
Yes
Compliance Check Decision Date
Compliance opinion date
14/06/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100845-PIP01-23-M02-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):CABOTEGRAVIR.pdf
Published Date 20/06/2023