Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Quintanrix
Auth. number : EU/1/04/301
INN : Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07C - Bacterial and viral vaccines, combined
Chemical subgroup: J07CA - Bacterial and viral vaccines, combined
Chemical substance: J07CA10 - Typhoid-hepatitis A
(See WHO ATC Index)
Indication: primary immunisation of infants against diphtheria, tetanus, pertussis, hepatitis B
Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.


European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
21/02/2005 Centralised - Authorisation EMEA/H/C/556 (2005)416 of 17/02/2005
17/05/2005 Centralised - Variation EMEA/H/C/556/IB/1
28/06/2005 Centralised - Variation EMEA/H/C/556/IA/6
30/06/2005 Centralised - Variation EMEA/H/C/556/II/2
30/06/2005 Centralised - Variation EMEA/H/C/556/II/2, 3, 4
29/09/2005 Centralised - Variation EMEA/H/C/556/IB/7
03/10/2005 Centralised - Variation EMEA/H/C/556/II/5
13/12/2007 Centralised - Variation EMEA/H/C/556/II/8 (2007)6412 of 11/12/2007
01/09/2008 Centralised - Withdrawal (2008)4745 of 28/08/2008