EMEA-000429-PIP01-08-M04

Table of contents

Key facts

Invented name
Nimenrix
Active substance
  • Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis group W polysaccharide conjugated to tetanus toxoid
  • N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
Therapeutic area
Vaccines
Decision number
P/0089/2015
PIP number
EMEA-000429-PIP01-08-M04
Pharmaceutical form(s)
Powder and solvent for solution for injection
Condition(s) / indication(s)
Prevention of Meningococcal disease
Route(s) of administration
Intramuscular use
Contact for public enquiries
GlaxoSmithKline Biologicals SA

Tel. +44 (0)20 8966 3220
E-mail: eu.paediatric-plans@gsk.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000429-PIP01-08-M04
Compliance opinion date
26/04/2019
Compliance outcome
positive

Decision

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