EMEA-001309-PIP01-12 - paediatric investigation plan

palivizumab
PIPHuman

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
Contact for public enquiries

AbbVie Ltd
E-mail: paediatricteam@abbvie.com
Tel. : +44 1628644475

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Compliance procedure number
EMEA-C-001309-PIP01-12
Compliance opinion date
Compliance outcome
Positive

Decision

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