EMA/PE/0000228372 - paediatric investigation plan

borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein vaccine

Key facts

• Active substance:
  borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein vaccine
• Therapeutic area:
  Infections and infestations
• Decision number:
  EMA/PE/0000228372
• PIP number:
  EMA/PE/0000228372
• Pharmaceutical form(s):
  Suspension for injection in pre-filled syringe
• Condition(s) / indication(s):
  Prevention of Lyme disease
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2025
• Compliance check done:
  Nie

Decision

EMA/PE/0000228372 : EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for Borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein vaccine

Adopted Reference Number: EMADOC-1700519818-2036729