EMEA-001418-PIP01-13-M05 - paediatric investigation plan

cabotegravir

Key facts

• Invented name:
  Vocabria
• Active substance:
  cabotegravir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0396/2022
• PIP number:
  EMEA-001418-PIP01-13-M05
• Pharmaceutical form(s):
  • Age appropriate oral dosage formulation
  • Film-coated tablet
  • Prolonged-release suspension for injection
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  • Intramuscular use
  • Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2022
• Compliance check done:
  No

Decision

P/0396/2022 : EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cabotegravir (Vocabria), (EMEA-001418-PIP01-13-M05)

Adopted Reference Number: EMA/709107/2022