EMEA-003130-PIP02-23 - 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:
  P/0080/2024
• PIP number:
  EMEA-003130-PIP02-23
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/03/2024

Decision

P/0080/2024 : EMA decision of 15 March 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein

AdoptedReference Number: EMA/28245/2024