EMEA-000500-PIP01-08-M03

Key facts

Active substance
  • Diphtheria toxoid
  • tetanus toxoid
  • Bordetella pertussis antigen: Pertussis toxoid
  • Bordetella pertussis antigen: Filamentous Haemagglutinin
  • Bordetella pertussis antigen: Pertactin
  • Inactivated poliovirus: type 1 (Mahoney strain)
  • Inactivated poliovirus: type 2 (MEF-1 strain)
  • Inactivated poliovirus: type 3 (Saukett strain)
Therapeutic area
Vaccines
Decision number
P/0035/2015
PIP number
EMEA-000500-PIP01-08-M03
Pharmaceutical form(s)
  • Suspension for injection
  • Suspension for injection in pre-filled syringe
Condition(s) / indication(s)
Prevention of infectious diseases caused by Corynebacterium diphtheriae / Clostridium tetani / Bordetella pertussis / Poliovirus types 1, 2 and 3
Route(s) of administration
Intramuscular use
Contact for public enquiries
GlaxoSmithKline Biologicals S.A. (Belgium)

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

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000500-PIP01-08-M03
Compliance opinion date
27/05/2016
Compliance outcome
positive

Decision

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