EMEA-001309-PIP01-12

Key facts

Invented name
Synagis
Active substance
palivizumab
Therapeutic area
Neonatology-Paediactric 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
Country: United Kingdom
Tel. +44 (0)1628 644475
Fax: +44 (0)1628 642566
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance procedure number
EMEA-C-001309-PIP01-12
Compliance opinion date
09/08/2013
Compliance outcome
positive

Decision

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