EMEA-002780-PIP02-20-M02 - paediatric investigation plan

Multivalent pneumococcal polysaccharide conjugate to carrier protein (PCV21)

Key facts

• Active substance:
  Multivalent pneumococcal polysaccharide conjugate to carrier protein (PCV21)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0288/2024
• PIP number:
  EMEA-002780-PIP02-20-M02
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of disease caused by Streptococcus pneumoniae
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/08/2024
• Compliance check done:
  No

Decision

P/0288/2024: EMA decision of 14 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for multivalent pneumococcal polysaccharide conjugate to carrier protein (PCV21) (EMEA-002780-PIP02-20-M02)

Adopted Reference Number: EMA/364892/2024