Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Synflorix   
Auth. number : EU/1/09/508
INN : Pneumococcal polysaccharide conjugate 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: J07AL52 - Pneumococcus purified polysaccharides antigen and Haemophilus influenzae, conjugated
(See WHO ATC Index)
Indication: Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age. See sections 4.4 and 5.1 of summary of product characteristics for information on protection against specific pneumococcal serotypes.

The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact on pneumococcal diseases in different age groups as well as the variability of the epidemiology in different geographical areas.
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
31/03/2009 Centralised - Authorisation EMEA/H/C/973 (2009)2563 of 30/03/2009
21/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/IA/2
08/05/2009 Centralised - Variation EMEA/H/C/973/IB/1
Updated with Decision(2009)10237 of 10/12/2009
08/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/II/4
13/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/II/3
31/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/IA/5
26/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/II/7
14/12/2009 Centralised - Variation (2009)10237 of 10/12/2009
04/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/II/10
04/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/II/9
04/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/II/11
04/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/II/6
08/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/IB/12
29/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/WS/1
30/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/IB/13
07/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/IB/19
10/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/IB/18
12/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/II/15
27/01/2011 Centralised - Variation EMEA/H/C/973/II/14, 16 (2011)461 of 24/01/2011
24/02/2011 Centralised - Variation (refusal) EMEA/H/C/973/IG/33/G
24/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/IB/19
02/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/IB/22
07/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/II/21
18/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/973/IG/62/G
28/03/2011 Centralised - Variation (refusal) EMEA/H/C/973/IG/51/G
27/04/2011 Centralised - Variation EMEA/H/C/973/IG/62/G
Updated with Decision(2011)4839 of 29/06/2011
05/07/2011 Centralised - Variation EMEA/H/C/973/II/24/G (2011)4839 of 29/06/2011
10/08/2011 Centralised - Variation EMEA/H/C/973/II/20 (2011)5842 of 05/08/2011
02/02/2012 Centralised - Variation EMEA/H/C/973/II/29 (2012)652 of 31/01/2012
07/09/2012 Centralised - Variation EMEA/H/C/973/IA/49/G
Updated with Decision(2012)7724 of 25/10/2012
29/10/2012 Centralised - Variation EMEA/H/C/973/II/44 (2012)7724 of 25/10/2012
17/05/2013 Centralised - Variation EMEA/H/C/973/IG/304
Updated with Decision(2013)8509 of 25/11/2013
30/05/2013 Centralised - Variation EMEA/H/C/973/II/51
Updated with Decision(2013)8509 of 25/11/2013
27/06/2013 Centralised - Variation EMEA/H/C/973/II/57
Updated with Decision(2013)8509 of 25/11/2013
19/09/2013 Centralised - Variation EMEA/H/C/973/II/71
Updated with Decision(2013)8509 of 25/11/2013
27/11/2013 Centralised - 2-Monthly update EMEA/H/C/973/II/52 (2013)8509 of 25/11/2013
23/01/2014 Centralised - Variation EMEA/H/C/973/II/70
20/02/2014 Centralised - Variation EMEA/H/C/973/II/69
25/02/2014 Centralised - Renewal EMEA/H/C/973/R/68 (2014)1310 of 21/02/2014
24/07/2014 Centralised - Variation EMEA/H/C/973/II/75
25/09/2014 Centralised - Variation EMEA/H/C/973/II/79