Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Infanrix hexa   
Auth. number : EU/1/00/152
INN : Infanrix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b.
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: J07CA09 - Diphtheria-hemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B
(See WHO ATC Index)
Indication: Primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis
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
27/10/2000 Centralised - Authorisation EMEA/H/C/296 (2000)2848 of 23/10/2000
16/07/2001 Centralised - Variation EMEA/H/C/296/I/5
16/07/2001 Centralised - Variation EMEA/H/C/296/I/6
16/07/2001 Centralised - Variation EMEA/H/C/296/I/4
16/07/2001 Centralised - Variation EMEA/H/C/296/I/8
16/07/2001 Centralised - Variation EMEA/H/C/296/I/1
16/07/2001 Centralised - Variation EMEA/H/C/296/I/2
17/07/2001 Centralised - Variation EMEA/H/C/296/I/7 (2001)2012 of 16/07/2001
24/09/2001 Centralised - Variation EMEA/H/C/296/II/9
02/10/2001 Centralised - Variation EMEA/H/C/296/II/10
27/11/2001 Centralised - Variation EMEA/H/C/296/II/3
28/11/2001 Centralised - Variation EMEA/H/C/296/I/11
28/11/2001 Centralised - Variation EMEA/H/C/296/I/15
24/12/2001 Centralised - Variation EMEA/H/C/296/I/12 (2001)4375 of 19/12/2001
08/02/2002 Centralised - Variation EMEA/H/C/296/I/13, 14 (2002)499 of 06/02/2002
07/06/2002 Centralised - Variation EMEA/H/C/296/II/16
27/09/2002 Centralised - Variation EMEA/H/C/296/I/19
29/10/2002 Centralised - Variation EMEA/H/C/296/II/17 (2002)4299 of 24/10/2002
30/10/2002 Centralised - Variation EMEA/H/C/296/II/18
10/03/2003 Centralised - Variation EMEA/H/C/296/II/20
10/03/2003 Centralised - Variation EMEA/H/C/296/I/21
27/03/2003 Centralised - Variation EMEA/H/C/296/I/22
03/07/2003 Centralised - Variation EMEA/H/C/296/I/24
05/08/2003 Centralised - Variation EMEA/H/C/296/N/29 (2003)2904 of 01/08/2003
11/08/2003 Centralised - Variation EMEA/H/C/296/II/23 (2003)2991 of 07/08/2003
18/09/2003 Centralised - Variation EMEA/H/C/296/I/25
23/09/2003 Centralised - Variation EMEA/H/C/296/I/28
03/10/2003 Centralised - Variation EMEA/H/C/296/I/27
24/11/2003 Centralised - Variation EMEA/H/C/296/II/26
29/01/2004 Centralised - Variation EMEA/H/C/296/II/30 (2004)239 of 27/01/2004
29/01/2004 Centralised - Variation EMEA/H/C/296/II/31 (2004)228 of 27/01/2004
01/03/2004 Centralised - Variation EMEA/H/C/296/II/33
17/03/2004 Centralised - Variation EMEA/H/C/296/IA/35
10/05/2004 Centralised - Variation EMEA/H/C/296/II/34
26/10/2004 Centralised - Variation EMEA/H/C/296/N/38
Updated with Decision(2005)3534 of 13/09/2005
22/12/2004 Centralised - Variation EMEA/H/C/296/IB/40
22/02/2005 Centralised - Variation EMEA/H/C/296/II/37
23/03/2005 Centralised - Variation EMEA/H/C/296/II/42
19/04/2005 Centralised - Variation EMEA/H/C/296/IA/45
30/06/2005 Centralised - Variation EMEA/H/C/296/II/41
03/08/2005 Centralised - Variation EMEA/H/C/296/IA/50
31/08/2005 Centralised - Variation EMEA/H/C/296/IA/52
06/09/2005 Centralised - Variation EMEA/H/C/296/IA/54
14/09/2005 Centralised - Variation EMEA/H/C/296/II/46 (2005)3534 of 13/09/2005
28/09/2005 Centralised - Variation EMEA/H/C/296/IB/53
03/10/2005 Centralised - Variation EMEA/H/C/296/II/47
21/11/2005 Centralised - Renewal EMEA/H/C/296/R/48 (2005)4543 of 17/11/2005
21/12/2005 Centralised - Variation EMEA/H/C/296/II/49
21/12/2005 Centralised - Variation EMEA/H/C/296/II/51
26/01/2006 Centralised - Variation EMEA/H/C/296/X/43 (2006)206 of 24/01/2006
07/03/2006 Centralised - Variation EMEA/H/C/296/II/44
01/08/2006 Centralised - Variation EMEA/H/C/296/II/57
25/09/2006 Centralised - Variation EMEA/H/C/296/II/55
21/11/2006 Centralised - Variation EMEA/H/C/296/II/61
19/12/2006 Centralised - Variation EMEA/H/C/296/II/63
26/02/2007 Centralised - Variation EMEA/H/C/296/II/59
26/02/2007 Centralised - Variation EMEA/H/C/296/II/64
17/04/2007 Centralised - Variation EMEA/H/C/296/II/58 (2007)1765 of 13/04/2007
07/05/2007 Centralised - Variation EMEA/H/C/296/II/62 (2007)2041 of 03/05/2007
10/05/2007 Centralised - Variation EMEA/H/C/296/II/60
20/07/2007 Centralised - Variation EMEA/H/C/296/IA/67
23/07/2007 Centralised - Variation EMEA/H/C/296/II/66
30/08/2007 Centralised - Variation EMEA/H/C/296/IA/69
Updated with Decision(2007)6803 of 20/12/2007
21/11/2007 Centralised - Variation EMEA/H/C/296/II/68
24/12/2007 Centralised - Variation EMEA/H/C/296/II/72 (2007)6803 of 20/12/2007
26/02/2008 Centralised - Variation EMEA/H/C/296/II/70
05/05/2008 Centralised - Variation EMEA/H/C/296/II/77
05/05/2008 Centralised - Variation EMEA/H/C/296/II/78
05/05/2008 Centralised - Variation EMEA/H/C/296/II/79
05/05/2008 Centralised - Variation EMEA/H/C/296/IA/80
05/06/2008 Centralised - Variation EMEA/H/C/296/II/76
05/06/2008 Centralised - Variation EMEA/H/C/296/II/71
30/06/2008 Centralised - Variation EMEA/H/C/296/IA/81
12/08/2008 Centralised - Variation EMEA/H/C/296/II/74 (2008)4415 of 08/08/2008
04/11/2008 Centralised - Variation EMEA/H/C/296/II/73 (2008)6661 of 31/10/2008
18/11/2008 Centralised - Variation EMEA/H/C/296/IA/82
23/12/2008 Centralised - Variation EMEA/H/C/296/IB/83
05/02/2009 Centralised - Variation EMEA/H/C/296/IA/88
12/02/2009 Centralised - Variation EMEA/H/C/296/IB/87
04/03/2009 Centralised - Variation EMEA/H/C/296/II/86
24/03/2009 Centralised - Variation EMEA/H/C/296/II/85
24/03/2009 Centralised - Variation EMEA/H/C/296/II/84
06/07/2009 Centralised - Variation EMEA/H/C/296/II/89
06/07/2009 Centralised - Variation EMEA/H/C/296/II/90
23/07/2009 Centralised - Variation EMEA/H/C/296/IB/91
21/09/2009 Centralised - Variation EMEA/H/C/296/IB/92
08/01/2010 Centralised - Variation EMEA/H/C/296/II/93
01/03/2010 Centralised - Variation EMEA/H/C/296/II/94
30/04/2010 Centralised - Variation EMEA/H/C/296/II/96
12/05/2010 Centralised - Variation EMEA/H/C/296/X/95 (2010)3183 of 10/05/2010
17/05/2010 Centralised - Variation EMEA/H/C/296/WS/1
14/06/2010 Centralised - Variation EMEA/H/C/296/IB/98
10/08/2010 Centralised - Variation EMEA/H/C/296/IA/101
25/08/2010 Centralised - Variation EMEA/H/C/296/IB/102
25/08/2010 Centralised - Variation EMEA/H/C/296/IB/100
03/09/2010 Centralised - Renewal EMEA/H/C/296/R/97 (2010)6113 of 31/08/2010
03/11/2010 Centralised - Variation EMEA/H/C/296/II/99
22/12/2010 Centralised - Variation EMEA/H/C/296/II/103
27/01/2011 Centralised - Variation EMEA/H/C/296/IB/104/G
24/02/2011 Centralised - Variation EMEA/H/C/296/IG/33/G
18/03/2011 Centralised - Variation EMEA/H/C/296/IA/105
Updated with Decision(2011)4346 of 15/06/2011
18/03/2011 Centralised - Variation EMEA/H/C/296/IG/52/G
31/03/2011 Centralised - Variation EMEA/H/C/296/IG/51/G
31/03/2011 Centralised - Variation EMEA/H/C/296/IG/52/G
17/06/2011 Centralised - Variation (2011)4346 of 15/06/2011
28/07/2011 Centralised - Variation EMEA/H/C/296/II/106 (2011)5531 of 26/07/2011
15/10/2013 Centralised - Variation EMEA/H/C/296/IAIN/137
20/03/2014 Centralised - Variation EMEA/H/C/296/II/138
22/05/2014 Centralised - Variation EMEA/H/C/296/II/139
23/06/2014 Centralised - Variation EMEA/H/C/296/IAin/160