Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


EXPIRED  

Product information

Invented name: Infanrix penta
Auth. number : EU/1/00/153
INN : Diphtheria, tetanus, acellular pertussis, hepatitis B recombinant (adsorbed), inactivated poliomyelitis vaccine
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: J07CA12 - Diphtheria-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/295 (2000)2846 of 23/10/2000
16/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/I/4
16/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/I/3
16/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/I/1
17/07/2001 Centralised - Variation EMEA/H/C/295/I/5 (2001)2013 of 16/07/2001
24/09/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/6
02/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/7
27/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/2
28/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/I/12
28/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/I/8
20/12/2001 Centralised - Variation EMEA/H/C/295/I/9 (2001)4346 of 18/12/2001
08/02/2002 Centralised - Variation EMEA/H/C/295/I/10, 11 (2002)500 of 06/02/2002
07/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/13
27/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/I/14
10/10/2002 Centralised - Notification EMEA/H/C/295/N/15 (2002)3843 of 08/10/2002
10/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/16
03/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/I/17
18/09/2003 Centralised - Notification EMEA/H/C/295/N/20 (2003)3346 of 16/09/2003
03/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/I/19
24/11/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/18
01/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/22
17/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IA/24
10/05/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/23
22/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IB/25
19/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IA/29
30/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/27
05/08/2005 Centralised - Notification EMEA/H/C/295/N/26
Updated with Decision(2005)3532 of 13/09/2005
31/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IA/34
06/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IA/36
14/09/2005 Centralised - Variation EMEA/H/C/295/II/30 (2005)3532 of 13/09/2005
28/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IB/35
03/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/31
21/11/2005 Centralised - Renewal EMEA/H/C/295/R/32 (2005)4540 of 17/11/2005
21/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/33
26/01/2006 Centralised - Variation EMEA/H/C/295/X/28 (2006)205 of 24/01/2006
22/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/40
26/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/42
17/04/2007 Centralised - Variation EMEA/H/C/295/II/38 (2007)1764 of 13/04/2007
07/05/2007 Centralised - Variation EMEA/H/C/295/II/41 (2007)2042 of 03/05/2007
10/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/39
20/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IA/44
30/08/2007 Centralised - Variation EMEA/H/C/295/IA/46
Updated with Decision(2007)6740 of 18/12/2007
21/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/45
20/12/2007 Centralised - Variation EMEA/H/C/295/II/48 (2007)6740 of 18/12/2007
05/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/53
05/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/52
05/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/47
08/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IA/54
18/08/2008 Centralised - Variation EMEA/H/C/295/II/50, 51 (2008)4539 of 13/08/2008
04/11/2008 Centralised - Variation EMEA/H/C/295/II/49 (2008)6608 of 30/10/2008
18/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IA/55
23/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IB/56
05/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IA/61
12/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IB/60
04/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/59
24/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/58
24/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/57
06/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/62
06/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/63
23/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IB/64
21/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IB/65
08/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/66
17/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/WS/1
10/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IA/70
25/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IB/69
25/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IB/71
03/09/2010 Centralised - Renewal EMEA/H/C/295/R/67 (2010)6114 of 31/08/2010
03/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/68
22/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/II/72
18/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/295/IG/52/G
31/03/2011 Centralised - Variation (refusal) EMEA/H/C/295/IG/51/G
21/12/2011 Centralised - Withdrawal