Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Prevenar   
Auth. number : EU/1/00/167
INN : pneumoccocal saccharide conjugated vaccine, adsorbed
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07A - Bacterial vaccines
Chemical subgroup: J07AL - Pneumococcal vaccines
Chemical substance: J07AL02 - Pneumococcus, purified polysaccharides antigen conjugated
(See WHO ATC Index)
Indication: Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from 2 months up to 5 years of age (see sections 4.2, 4.4 and 5.1).For the number of doses to be administered in the different age groups, see section 4.2.The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas (see sections 4.4, 4.8 and 5.1).
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

  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
03/02/2001 Centralised - Authorisation EMEA/H/C/323 (2001)210 of 02/02/2001
08/08/2001 Centralised - Variation EMEA/H/C/323/II/1 (2001)2090 of 06/08/2001
31/01/2002 Centralised - Variation EMEA/H/C/323/II/4 (2002)402 of 28/01/2002
04/02/2002 Centralised - Variation EMEA/H/C/323/II/2, 3 (2002)419 of 29/01/2002
25/02/2002 Centralised - Variation EMEA/H/C/323/II/5 (2002)659 of 19/02/2002
05/03/2002 Centralised - Variation EMEA/H/C/323/N/6 (2002)940 of 28/02/2002
28/06/2002 Centralised - Variation EMEA/H/C/323/I/7
08/10/2002 Centralised - Variation EMEA/H/C/323/I/10
21/10/2002 Centralised - Variation EMEA/H/C/323/I/11 (2002)4059 of 17/10/2002
10/12/2002 Centralised - Variation EMEA/H/C/323/II/9 (2002)5043 of 06/12/2002
28/05/2003 Centralised - Variation EMEA/H/C/323/II/12
10/06/2003 Centralised - Variation EMEA/H/C/323/I/13
05/08/2003 Centralised - Variation EMEA/H/C/323/I/14
13/08/2003 Centralised - Variation EMEA/H/C/323/I/16 (2003)3036 of 11/08/2003
18/09/2003 Centralised - Variation EMEA/H/C/323/II/8 (2003)3331 of 16/09/2003
19/02/2004 Centralised - Variation EMEA/H/C/323/IB/20, 22
19/02/2004 Centralised - Variation EMEA/H/C/323/IB/24, 25
15/04/2004 Centralised - Variation EMEA/H/C/323/IA/30
27/04/2004 Centralised - Variation EMEA/H/C/323/II/19
24/05/2004 Centralised - Variation EMEA/H/C/323/IA/34
Updated with Decision(2004)3032 of 02/08/2004
24/05/2004 Centralised - Variation EMEA/H/C/323/IA/35
Updated with Decision(2004)3032 of 02/08/2004
09/06/2004 Centralised - Variation EMEA/H/C/323/IA/40
01/07/2004 Centralised - Variation EMEA/H/C/323/II/26
01/07/2004 Centralised - Variation EMEA/H/C/323/II/29
09/07/2004 Centralised - Variation EMEA/H/C/323/IA/44
09/07/2004 Centralised - Variation EMEA/H/C/323/IA/45
22/07/2004 Centralised - Variation EMEA/H/C/323/IA/49
30/07/2004 Centralised - Variation EMEA/H/C/323/IB/46
02/08/2004 Centralised - Variation EMEA/H/C/323/II/38
02/08/2004 Centralised - Variation EMEA/H/C/323/II/31
02/08/2004 Centralised - Variation EMEA/H/C/323/II/37
02/08/2004 Centralised - Variation EMEA/H/C/323/II/32
02/08/2004 Centralised - Variation EMEA/H/C/323/II/33
04/08/2004 Centralised - Variation EMEA/H/C/323/II/18 (2004)3032 of 02/08/2004
13/09/2004 Centralised - Variation EMEA/H/C/323/IB/47
22/09/2004 Centralised - Variation EMEA/H/C/323/II/41
22/09/2004 Centralised - Variation EMEA/H/C/323/II/42
28/10/2004 Centralised - Variation EMEA/H/C/323/IA/55
09/11/2004 Centralised - Variation EMEA/H/C/323/IB/53
22/11/2004 Centralised - Variation EMEA/H/C/323/II/48
21/12/2004 Centralised - Variation EMEA/H/C/323/II/36
21/12/2004 Centralised - Variation EMEA/H/C/323/II/36
11/01/2005 Centralised - Variation EMEA/H/C/323/IB/57
11/01/2005 Centralised - Variation EMEA/H/C/323/IA/59
14/01/2005 Centralised - Variation EMEA/H/C/323/IA/58
Updated with Decision(2005)3792 of 05/10/2005
28/01/2005 Centralised - Variation EMEA/H/C/323/II/52 (2005)235 of 26/01/2005
24/02/2005 Centralised - Variation EMEA/H/C/323/II/54
24/02/2005 Centralised - Variation EMEA/H/C/323/II/56
05/04/2005 Centralised - Variation EMEA/H/C/323/IB/60
01/06/2005 Centralised - Variation EMEA/H/C/323/II/62
28/06/2005 Centralised - Variation EMEA/H/C/323/IB/65
28/06/2005 Centralised - Variation EMEA/H/C/323/IB/64
11/08/2005 Centralised - Variation EMEA/H/C/323/N/61
Updated with Decision(2005)3792 of 05/10/2005
23/09/2005 Centralised - Variation EMEA/H/C/323/II/63
07/10/2005 Centralised - Variation (2005)3792 of 05/10/2005
31/10/2005 Centralised - Variation EMEA/H/C/323/II/66 (2005)4294 of 27/10/2005
30/01/2006 Centralised - Variation EMEA/H/C/323/IA/71
28/03/2006 Centralised - Variation EMEA/H/C/323/II/69
19/04/2006 Centralised - Renewal EMEA/H/C/323/R/67 (2006)1669 of 12/04/2006
02/05/2006 Centralised - Variation EMEA/H/C/323/II/68
02/05/2006 Centralised - Variation EMEA/H/C/323/II/70
02/05/2006 Centralised - Variation EMEA/H/C/323/II/72
17/05/2006 Centralised - Variation EMEA/H/C/323/IB/73
13/06/2006 Centralised - Variation EMEA/H/C/323/IA/77
16/06/2006 Centralised - Variation EMEA/H/C/323/IB/74
19/07/2006 Centralised - Variation EMEA/H/C/323/IA/79
07/08/2006 Centralised - Variation EMEA/H/C/323/IA/81
16/08/2006 Centralised - Variation EMEA/H/C/323/IA/83
26/09/2006 Centralised - Variation EMEA/H/C/323/II/78
24/10/2006 Centralised - Variation EMEA/H/C/323/II/82
22/11/2006 Centralised - Variation EMEA/H/C/323/II/75
22/11/2006 Centralised - Variation EMEA/H/C/323/II/88
15/12/2006 Centralised - Variation EMEA/H/C/323/IB/86
27/02/2007 Centralised - Variation EMEA/H/C/323/II/89
27/02/2007 Centralised - Variation EMEA/H/C/323/II/92
27/02/2007 Centralised - Variation EMEA/H/C/323/II/87
13/03/2007 Centralised - Variation EMEA/H/C/323/II/76, 90 (2007)1198 of 09/03/2007
04/04/2007 Centralised - Variation EMEA/H/C/323/II/80 (2007)1592 of 02/04/2007
11/04/2007 Centralised - Variation EMEA/H/C/323/IA/96
02/05/2007 Centralised - Variation EMEA/H/C/323/II/93
02/05/2007 Centralised - Variation EMEA/H/C/323/II/94
07/05/2007 Centralised - Variation EMEA/H/C/323/IA/98
16/05/2007 Centralised - Variation EMEA/H/C/323/IB/97
07/06/2007 Centralised - Variation EMEA/H/C/323/IB/99
01/08/2007 Centralised - Variation EMEA/H/C/323/II/100
01/08/2007 Centralised - Variation EMEA/H/C/323/II/95 (2007)3760 of 30/07/2007
03/08/2007 Centralised - Variation EMEA/H/C/323/IA/101
03/09/2007 Centralised - Variation EMEA/H/C/323/IA/104
06/09/2007 Centralised - Variation EMEA/H/C/323/X/91 (2007)4197 of 31/08/2007
23/10/2007 Centralised - Variation EMEA/H/C/323/II/103
13/12/2007 Centralised - Variation EMEA/H/C/323/II/109 (2007)6419 of 11/12/2007
19/12/2007 Centralised - Variation EMEA/H/C/323/II/108
20/12/2007 Centralised - Variation EMEA/H/C/323/IB/110
10/01/2008 Centralised - Variation EMEA/H/C/323/IA/113
29/01/2008 Centralised - Variation EMEA/H/C/323/II/105
08/02/2008 Centralised - Variation EMEA/H/C/323/II/102 (2008)534 of 06/02/2008
28/03/2008 Centralised - Variation EMEA/H/C/323/II/114
04/04/2008 Centralised - Variation EMEA/H/C/323/IA/117
Updated with Decision(2008)3192 of 20/06/2008
11/06/2008 Centralised - Variation EMEA/H/C/323/II/116, 118
24/06/2008 Centralised - Variation EMEA/H/C/323/II/107 (2008)3192 of 20/06/2008
02/07/2008 Centralised - Variation EMEA/H/C/323/IB/123
04/07/2008 Centralised - Variation EMEA/H/C/323/II/120
04/07/2008 Centralised - Variation EMEA/H/C/323/II/115
31/07/2008 Centralised - Variation EMEA/H/C/323/II/112
04/08/2008 Centralised - Variation EMEA/H/C/323/IA/126
18/08/2008 Centralised - Variation EMEA/H/C/323/IA/127
02/10/2008 Centralised - Variation EMEA/H/C/323/II/122
02/10/2008 Centralised - Variation EMEA/H/C/323/II/125
02/10/2008 Centralised - Variation EMEA/H/C/323/II/121
28/11/2008 Centralised - Variation EMEA/H/C/323/II/111
28/11/2008 Centralised - Variation EMEA/H/C/323/II/124
19/12/2008 Centralised - Variation EMEA/H/C/323/IB/132
Updated with Decision(2009)5509 of 03/07/2009
05/01/2009 Centralised - Variation EMEA/H/C/323/II/128
08/01/2009 Centralised - Variation EMEA/H/C/323/II/119 (2009)28 of 06/01/2009
27/01/2009 Centralised - Variation EMEA/H/C/323/II/129
27/01/2009 Centralised - Variation EMEA/H/C/323/II/131
09/03/2009 Centralised - Variation EMEA/H/C/323/II/133
09/03/2009 Centralised - Variation EMEA/H/C/323/II/130
09/03/2009 Centralised - Variation EMEA/H/C/323/II/134
25/03/2009 Centralised - Variation EMEA/H/C/323/II/136
26/03/2009 Centralised - Variation EMEA/H/C/323/II/135
05/05/2009 Centralised - Variation EMEA/H/C/323/IB/141
10/06/2009 Centralised - Variation EMEA/H/C/323/IA/145
10/06/2009 Centralised - Variation EMEA/H/C/323/IA/146
10/06/2009 Centralised - Variation EMEA/H/C/323/IA/144
16/06/2009 Centralised - Variation EMEA/H/C/323/II/139
30/06/2009 Centralised - Variation EMEA/H/C/323/II/140
07/07/2009 Centralised - Variation EMEA/H/C/323/II/138 (2009)5509 of 03/07/2009
08/07/2009 Centralised - Variation EMEA/H/C/323/IA/147
29/07/2009 Centralised - Variation EMEA/H/C/323/II/143
30/07/2009 Centralised - Variation EMEA/H/C/323/II/142 (2009)6112 of 27/07/2009
08/10/2009 Centralised - Variation EMEA/H/C/323/II/148
22/03/2010 Centralised - Variation EMEA/H/C/323/N/149
Updated with Decision(2010)3489 of 26/05/2010
14/04/2010 Centralised - Variation EMEA/H/C/323/IA/153
Updated with Decision(2010)3489 of 26/05/2010
14/04/2010 Centralised - Variation EMEA/H/C/323/IA/150
Updated with Decision(2010)3489 of 26/05/2010
14/04/2010 Centralised - Variation EMEA/H/C/323/IA/151
Updated with Decision(2010)3489 of 26/05/2010
14/04/2010 Centralised - Variation EMEA/H/C/323/IA/152
Updated with Decision(2010)3489 of 26/05/2010
14/04/2010 Centralised - Variation EMEA/H/C/323/IA/154
Updated with Decision(2010)3489 of 26/05/2010
28/05/2010 Centralised - Variation (2010)3489 of 26/05/2010
13/12/2010 Centralised - Variation EMEA/H/C/323/IA/156
Updated with Decision(2011)722 of 02/02/2011
04/02/2011 Centralised - Renewal EMEA/H/C/323/R/155 (2011)722 of 02/02/2011
06/05/2011 Centralised - Variation EMEA/H/C/323/WS/117
20/06/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/323/T/159 (2012)4210 of 15/06/2012
15/11/2012 Centralised - Variation EMEA/H/C/323/II/161
Updated with Decision(2013)8703 of 29/11/2013
03/12/2013 Centralised - Variation (2013)8703 of 29/11/2013
06/05/2014 Centralised - Variation EMEA/H/C/323/N/Ol67