🇪🇺 diphtheria, tetanus, pertussis & Hib vaccine in European Union

EMA authorised diphtheria, tetanus, pertussis & Hib vaccine on 30 July 1997

Marketing authorisations

Application: EMEA/H/C/000126
Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
Local brand name: Infanrix HepB
Indication: Infanrix HepB is indicated for active immunisation of all infants from the age of 2 months againstdiphtheria, tetanus, pertussis and hepatitis B.
Status: withdrawn

Application: EMEA/H/C/000156
Marketing authorisation holder: Pasteur Mà¨rieux MSD
Local brand name: Primavax
Indication: This vaccine is indicated for active immunization against hepatitis B, caused by all known subtypes, diphtheria and tetanus in infants :- for primary vaccination- for boosteraccording to national vaccination policies.This vaccine should not be administered to neonates.This vaccine is not intended for use in adolescents or adults.
Status: withdrawn

Application: EMEA/H/C/000181
Marketing authorisation holder: Chiron S.p.A.
Local brand name: Triacelluvax
Indication: TRIACELLUVAX is indicated for active immunisation of children from 6 weeks up to 7 years of age against diphtheria, tetanus and pertussis.
Status: withdrawn

Application: EMEA/H/C/000298
Marketing authorisation holder: Sanofi Pasteur MSD, SNC
Local brand name: Hexavac
Indication: This combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.
Status: withdrawn

Application: EMEA/H/C/000556
Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
Local brand name: Quintanrix
Indication: Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae type b and for booster immunisation of young children during the second year of life.The use of Quintanrix should be determined on the basis of official recommendations.
Status: withdrawn

Is diphtheria, tetanus, pertussis & Hib vaccine approved in European Union?

Yes. EMA authorised it on 30 July 1997; EMA authorised it on 5 February 1998; EMA authorised it on 11 January 1999.

Who is the marketing authorisation holder for diphtheria, tetanus, pertussis & Hib vaccine in European Union?

GlaxoSmithKline Biologicals S.A. holds the EU marketing authorisation.