EMEA-002330-PIP01-18-M03 - paediatric investigation plan

Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)

Key facts

• Invented name:
  Prevenar 20 (previously Apexxnar)
• Active substance:
  Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0246/2023
• PIP number:
  EMEA-002330-PIP01-18-M03
• 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:
  14/07/2023
• Compliance check done:
  No

Decision

P/0246/2023 : EMA decision of 14 July 2023 on the acceptance of a modification of an agreed paediatric investigation plan for pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) (Apexxnar), (EMEA-002330-PIP01-18-M03)

Reference Number: EMA/287622/2023