EMEA-001418-PIP02-15-M03 - paediatric investigation plan

cabotegravir

Key facts

• Invented name:
  Vocabria
• Active substance:
  cabotegravir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0102/2022
• PIP number:
  EMEA-001418-PIP02-15-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Prolonged-release suspension for injection
• Condition(s) / indication(s):
  Prevention of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  • Oral use
  • Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/03/2022
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001418-PIP02-15-M03
• Compliance opinion date:
  20/05/2022
• Compliance outcome:
  Positive

Decision

P/0102/2022 : EMA decision of 17 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cabotegravir (Vocabria) (EMEA-001418-PIP02-15-M03)

Adopted Reference Number: EMA/150156/2022 Corr