EMEA-000352-PIP01-08-M01 - paediatric investigation plan

motavizumab

Key facts

• Active substance:
  motavizumab
• Therapeutic area:
  Neonatology-Paediatric Intensive Care
• Decision number:
  P/199/2010
• PIP number:
  EMEA-000352-PIP01-08-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Serious lower respiratory tract disease caused by respiratory syncytial virus (RSV)
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/10/2010
• Compliance check done:
  No

Decision

P/199/2010: European Medicines Agency decision of 27 October 2010 on the acceptance of a modification of an agreed paediatric investigation plan for motavizumab (EMEA-000352-PIP01-08-M01)

Adopted Reference Number: EMA/651476/2010