EMEA-001260-PIP01-11-M02

Key facts

Active substance
  • outer membrane vesicles (OMV) from n. meningitidis strain NZ 98/254
  • recombinant neisseria meningitis group B Protein 936-741
  • meningococcal group W-135 oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein
  • meningococcal group A oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein
  • meningococcal group C oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein
  • recombinant neisseria meningitis group B Protein 287-953
  • recombinant neisseria meningitis group B Protein 961c
  • meningococcal group Y oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein (MenABCWY)
Therapeutic area
Vaccines
Decision number
P/0437/2022
PIP number
EMEA-001260-PIP01-11-M02
Pharmaceutical form(s)
Powder and suspension for suspension for injection
Condition(s) / indication(s)
Prevention of meningococcal meningitis
Route(s) of administration
Intramuscular use
Contact for public enquiries
GlaxoSmithKline Biologicals SA
E-mail: eu.paediatric-plans@gsk.com
Tel: +1 4388998201
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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