Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Prevenar 13   
Auth. number : EU/1/09/590
Active substance : Pneumococcal polysaccharide conjugate vaccine (13-valent, 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 for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.
Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly.

The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.
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
11/12/2009 Centralised - Authorisation EMEA/H/C/1104 (2009)10142 of 09/12/2009
10/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/IB/3
22/03/2010 Centralised - Notification EMEA/H/C/1104/N/2
Updated with Decision(2010)5399 of 28/07/2010
24/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/II/1
31/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/IB/6
31/03/2010 Centralised - Variation EMEA/H/C/1104/IA/11
Updated with Decision(2010)5399 of 28/07/2010
31/03/2010 Centralised - Variation EMEA/H/C/1104/IA/9
Updated with Decision(2010)5399 of 28/07/2010
31/03/2010 Centralised - Variation EMEA/H/C/1104/IA/8
Updated with Decision(2010)5399 of 28/07/2010
31/03/2010 Centralised - Variation EMEA/H/C/1104/IA/7
Updated with Decision(2010)5399 of 28/07/2010
31/03/2010 Centralised - Variation EMEA/H/C/1104/IA/10
Updated with Decision(2010)5399 of 28/07/2010
04/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/II/4
18/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/IB/12
19/05/2010 Centralised - Variation EMEA/H/C/1104/IB/13
Updated with Decision(2010)5399 of 28/07/2010
28/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/IB/18
03/08/2010 Centralised - Variation (2010)5399 of 28/07/2010
16/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/II/15/G
06/09/2010 Centralised - Variation EMEA/H/C/1104/II/16 (2010)6142 of 01/09/2010
30/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/II/14
30/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/II/17
25/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/II/21, 21
01/12/2010 Centralised - Variation EMEA/H/C/1104/II/19 (2010)8549 of 26/11/2010
08/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/IB/22/G
13/12/2010 Centralised - Variation EMEA/H/C/1104/IA/23
Updated with Decision(2011)4843 of 29/06/2011
14/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/IB/25
01/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/II/24/G
04/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/IB/29
22/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/IB/26/G
23/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/IB/30
23/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/IB/27
06/05/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/WS/117
21/06/2011 Centralised - Variation EMEA/H/C/1104/IA/40/G
Updated with Decision(2011)4843 of 29/06/2011
05/07/2011 Centralised - Variation (2011)4843 of 29/06/2011
29/07/2011 Corrigendum (2011)5587 of 20/07/2011
22/08/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/IA/31
26/10/2011 Centralised - Variation EMEA/H/C/1104/II/28 (2011)7797 of 24/10/2011
22/03/2012 Centralised - Variation EMEA/H/C/1104/II/41 (2012)1927 of 19/03/2012
05/07/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1104/T/61 (2012)4707 of 03/07/2012
18/10/2012 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1104/II/56
21/10/2012 Centralised - Variation EMEA/H/C/1104/IB/69
Updated with Decision(2012)8712 of 22/11/2012
27/11/2012 Centralised - Variation EMEA/H/C/1104/II/56, 59 (2012)8712 of 22/11/2012
02/01/2013 Centralised - 2-Monthly update EMEA/H/C/1104/II/55 (2012)9942 of 20/12/2012
21/03/2013 Centralised - Variation EMEA/H/C/1104/II/75/G
Updated with Decision(2013)4445 of 09/07/2013
11/07/2013 Centralised - Variation EMEA/H/C/1104/II/71 (2013)4445 of 09/07/2013
19/09/2013 Centralised - Variation EMEA/H/C/1104/II/87
Updated with Decision(2013)8344 of 20/11/2013
19/09/2013 Centralised - Variation EMEA/H/C/1104/II/76
Updated with Decision(2013)8344 of 20/11/2013
22/11/2013 PSUSA - Maintain EMEA/H/C/1104/PSUV/90 (2013)8344 of 20/11/2013
20/12/2013 Centralised - Variation EMEA/H/C/1104/IA/97/G
Updated with Decision(2014)4360 of 23/06/2014
20/02/2014 Centralised - Variation EMEA/H/C/1104/II/100
Updated with Decision(2014)4360 of 23/06/2014
25/06/2014 Centralised - 2-Monthly update EMEA/H/C/1104/II/98 (2014)4360 of 23/06/2014
22/09/2014 Centralised - Renewal EMEA/H/C/1104/R/104 (2014)6801 of 18/09/2014
20/11/2014 Centralised - Variation EMEA/H/C/1104/II/106
Updated with Decision(2015)1430 of 26/02/2015
02/03/2015 Centralised - 2-Monthly update EMEA/H/C/1104/II/111 (2015)1430 of 26/02/2015