EMEA-001260-PIP01-11-M01

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/0231/2020
PIP number
EMEA-001260-PIP01-11-M01
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
GSK Vaccines S.r.l.

Tel. +1 438 899 8201
Email: eu.paediatric-plans@gsk.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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