Quintanrix

diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus influenzae type B conjugate vaccine (absorbed)

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The marketing authorisation for Quintanrix has been withdrawn at the request of the marketing authorisation holder

Name Language First published Last updated
Quintanrix : EPAR - Summary for the public BG = bălgarski 10/09/2008  
Quintanrix : EPAR - Summary for the public ES = español 10/09/2008  
Quintanrix : EPAR - Summary for the public CS = čeština 10/09/2008  
Quintanrix : EPAR - Summary for the public DA = dansk 10/09/2008  
Quintanrix : EPAR - Summary for the public DE = Deutsch 10/09/2008  
Quintanrix : EPAR - Summary for the public ET = eesti keel 10/09/2008  
Quintanrix : EPAR - Summary for the public EL = elliniká 10/09/2008  
Quintanrix : EPAR - Summary for the public EN = English 10/09/2008  
Quintanrix : EPAR - Summary for the public FR = français 10/09/2008  
Quintanrix : EPAR - Summary for the public IT = italiano 10/09/2008  
Quintanrix : EPAR - Summary for the public LV = latviešu valoda 10/09/2008  
Quintanrix : EPAR - Summary for the public LT = lietuvių kalba 10/09/2008  
Quintanrix : EPAR - Summary for the public HU = magyar 10/09/2008  
Quintanrix : EPAR - Summary for the public MT = Malti 10/09/2008  
Quintanrix : EPAR - Summary for the public NL = Nederlands 10/09/2008  
Quintanrix : EPAR - Summary for the public PL = polski 10/09/2008  
Quintanrix : EPAR - Summary for the public PT = português 10/09/2008  
Quintanrix : EPAR - Summary for the public RO = română 10/09/2008  
Quintanrix : EPAR - Summary for the public SK = slovenčina 10/09/2008  
Quintanrix : EPAR - Summary for the public SL = slovenščina 10/09/2008  
Quintanrix : EPAR - Summary for the public FI = suomi 10/09/2008  
Quintanrix : EPAR - Summary for the public SV = svenska 10/09/2008  

This EPAR was last updated on 10/09/2008 .

More detail is available in the summary of product characteristics

Authorisation details

Product details

Product details for Quintanrix
NameQuintanrix
Agency product numberEMEA/H/C/000556
Active substance

Bordetella pertussis, inactivated, diphtheria toxoid, Haemophilus influenza type B, hepatitis B recomb. surface antigen adsorbed, inactivated Bordetella pertussis, tetanus toxoid

International non-proprietary name (INN) or common name

diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus influenzae type B conjugate vaccine (absorbed)

Therapeutic area Meningitis, HaemophilusHepatitis BDiphtheriaWhooping CoughImmunizationTetanus
Anatomical therapeutic chemical (ATC) code J07CA10

Publication details

Publication details for Quintanrix
Marketing-authorisation holder

GlaxoSmithKline Biologicals S.A.

Revision2
Date of issue of marketing authorisation valid throughout the European Union17/02/2005

Contact address:

GlaxoSmithKline Biologicals S.A.
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

Product information

11/12/2007  Quintanrix -EMEA/H/C/000556 -II/0008

Name Language First published Last updated
Quintanrix : EPAR - Product Information BG = bălgarski 10/09/2008  
Quintanrix : EPAR - Product Information ES = español 10/09/2008  
Quintanrix : EPAR - Product Information CS = čeština 10/09/2008  
Quintanrix : EPAR - Product Information DA = dansk 10/09/2008  
Quintanrix : EPAR - Product Information DE = Deutsch 10/09/2008  
Quintanrix : EPAR - Product Information ET = eesti keel 10/09/2008  
Quintanrix : EPAR - Product Information EL = elliniká 10/09/2008  
Quintanrix : EPAR - Product Information EN = English 10/09/2008  
Quintanrix : EPAR - Product Information FR = français 10/09/2008  
Quintanrix : EPAR - Product Information IT = italiano 10/09/2008  
Quintanrix : EPAR - Product Information LV = latviešu valoda 10/09/2008  
Quintanrix : EPAR - Product Information LT = lietuvių kalba 10/09/2008  
Quintanrix : EPAR - Product Information HU = magyar 10/09/2008  
Quintanrix : EPAR - Product Information MT = Malti 10/09/2008  
Quintanrix : EPAR - Product Information NL = Nederlands 10/09/2008  
Quintanrix : EPAR - Product Information PL = polski 10/09/2008  
Quintanrix : EPAR - Product Information PT = português 10/09/2008  
Quintanrix : EPAR - Product Information RO = română 10/09/2008  
Quintanrix : EPAR - Product Information SK = slovenčina 10/09/2008  
Quintanrix : EPAR - Product Information SL = slovenščina 10/09/2008  
Quintanrix : EPAR - Product Information FI = suomi 10/09/2008  
Quintanrix : EPAR - Product Information SV = svenska 10/09/2008  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Name Language First published Last updated
Quintanrix : EPAR - All Authorised presentations ES = español 10/09/2008  
Quintanrix : EPAR - All Authorised presentations CS = čeština 10/09/2008  
Quintanrix : EPAR - All Authorised presentations DA = dansk 10/09/2008  
Quintanrix : EPAR - All Authorised presentations DE = Deutsch 10/09/2008  
Quintanrix : EPAR - All Authorised presentations ET = eesti keel 10/09/2008  
Quintanrix : EPAR - All Authorised presentations EL = elliniká 10/09/2008  
Quintanrix : EPAR - All Authorised presentations EN = English 10/09/2008  
Quintanrix : EPAR - All Authorised presentations FR = français 10/09/2008  
Quintanrix : EPAR - All Authorised presentations IT = italiano 10/09/2008  
Quintanrix : EPAR - All Authorised presentations LV = latviešu valoda 10/09/2008  
Quintanrix : EPAR - All Authorised presentations LT = lietuvių kalba 10/09/2008  
Quintanrix : EPAR - All Authorised presentations HU = magyar 10/09/2008  
Quintanrix : EPAR - All Authorised presentations NL = Nederlands 10/09/2008  
Quintanrix : EPAR - All Authorised presentations PL = polski 10/09/2008  
Quintanrix : EPAR - All Authorised presentations PT = português 10/09/2008  
Quintanrix : EPAR - All Authorised presentations SK = slovenčina 10/09/2008  
Quintanrix : EPAR - All Authorised presentations SL = slovenščina 10/09/2008  
Quintanrix : EPAR - All Authorised presentations FI = suomi 10/09/2008  
Quintanrix : EPAR - All Authorised presentations SV = svenska 10/09/2008  

Pharmacotherapeutic group

Vaccines

Therapeutic 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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Quintanrix : EPAR - Procedural steps taken and scientific information after authorisation (English only) 10/09/2008  

Initial marketing-authorisation documents

Name Language First published Last updated
Quintanrix : EPAR - Scientific Discussion (English only) 10/09/2008  
Quintanrix : EPAR - Procedural steps taken before authorisation (English only) 10/09/2008  

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Quintanrix