MHRA-100901-PIP01-23-M02 (update)

Key Facts

Active Substance
Active Substance:
  • CABOTEGRAVIR
Invented Name
  • Vocabria
  • Vocabria / Cabenuva
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria
  • Vocabria / Cabenuva
  • Vocabria / Cabenuva
  • Vocabria
PIP Number MHRA-100901-PIP01-23-M02 (update)
Pharmaceutical form(s)
  • Prolonged-release suspension for injection
  • Film-coated tablet
  • Age-appropriate oral dosage form
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of human immunodeficiency virus (HIV-1) infection
Route(s) of administration
  • intramuscular
  • Oral use
PIP applicant
  • ViiV Healthcare UK Limited
  • Country United Kingdom
  • Tel 00442080475000
  • 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
09/11/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100901-PIP01-23-M02-C1

Decision Document

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