EMEA-000673-PIP01-09-M09 - paediatric investigation plan

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...

Key facts

• Invented name:
  • Synflorix
  • 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)

  E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/08/2016
• Compliance procedure number:
  EMEA-000673-PIP01-09-M09
• Compliance opinion date:
  27/01/2017
• Compliance outcome:
  Positive

Decision

P/0209/2016: EMA decision of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for pneumococcal polysaccharide serotype 6B conjugated to protein D ... (EMEA-000673-PIP01-09-M0...

AdoptedReference Number: EMA/520305/2016