EMEA-002954-PIP02-21 - paediatric investigation plan

Neisseria meningitidis serogroup B Protein-based active substance

Recombinant Neisseria meningitidis serogroup B protein 1

Recombinant Neisseria meningitidis serogroup B protein 2

Recombinant Neisseria meningitidis serogroup B protein 3

Key facts

• Active Substance:
  • Neisseria meningitidis serogroup B Protein-based active substance
  • Recombinant Neisseria meningitidis serogroup B protein 1
  • Recombinant Neisseria meningitidis serogroup B protein 2
  • Recombinant Neisseria meningitidis serogroup B protein 3
• Therapeutic area:
  Vaccines
• Decision number:
  P/0473/2021
• PIP number:
  EMEA-002954-PIP02-21
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of Meningococcal disease
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Sanofi Pasteur

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  03/12/2021

Decision

P/0473/2021 - EMA decision of 3 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant Neisseria... (EMEA-002954-PIP02-21)

AdoptedReference Number: P/0473/2021