EMEA-000673-PIP01-09-M09

Key facts

Invented name
Synflorix
Active substance
  • Pneumococcal polysaccharide serotype 1 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein
  • pneumococcal polysaccharide serotype 4 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein
  • pneumococcal polysaccharide serotype 5 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein...
Therapeutic area
Vaccines
Decision number
P/0209/2016
PIP number
EMEA-000673-PIP01-09-M09
Pharmaceutical form(s)
Suspension for injection
Condition(s) / indication(s)
Prevention of acute otitis media caused by non-typeable Haemophilus influenzae
Route(s) of administration
Intramuscular use
Contact for public enquiries
GlaxoSmithKline Biologicals S.A. (UK)

United Kingdom
Tel. +44 (0)20 8966 3220
Fax +44 (0)20 8966 2221
E-mail: eu.paediatric-plans@gsk.com

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-000673-PIP01-09-M09
Compliance opinion date
27/01/2017
Compliance outcome
positive

Decision

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