EMEA-001309-PIP01-12 - paediatric investigation plan

palivizumab

Key facts

• Invented name:
  • Synagis
  • Synagis
• Active substance:
  palivizumab
• Therapeutic area:
  Neonatology-Paediatric Intensive Care
• Decision number:
  P/0111/2013
• PIP number:
  EMEA-001309-PIP01-12
• Pharmaceutical form(s):
  • Solution for injection
  • Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Prevention of lower respiratory tract disease caused by respiratory syncytial virus
• 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:
  30/04/2013
• Compliance check done:
  Oui
• Compliance procedure number:
  EMEA-C-001309-PIP01-12
• Compliance opinion date:
  09/08/2013
• Compliance outcome:
  Positive

Decision

P/0111/2013: EMA decision of 30 April 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for palivizumab (Synagis) (EMEA-001309-PIP01-12)

Adopted Reference Number: EMA/203434/2013