EMEA-001309-PIP01-12

Key facts

Invented name
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
Fax: +44 1628672551


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

Related content

How useful was this page?

Add your rating