Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cervarix   
Auth. number : EU/1/07/419
INN : Human Papilloma Virus-16 and Human Papilloma Virus 18 L1 proteins
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BM - Papillomavirus vaccines
Chemical substance: J07BM02 - Papillomavirus (human types 16, 18)
(See WHO ATC Index)
Indication: Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types. See sections 4.4 and 5.1 for important information on the data that support this indication.
The use of Cervarix should be in accordance with official recommendations.
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
24/09/2007 Centralised - Authorisation EMEA/H/C/721 (2007)4440 of 20/09/2007
21/05/2008 Centralised - Variation EMEA/H/C/721/IA/3
18/08/2008 Centralised - Variation EMEA/H/C/721/II/1 (2008)4540 of 13/08/2008
03/10/2008 Centralised - Variation EMEA/H/C/721/II/2
28/11/2008 Centralised - Variation EMEA/H/C/721/II/4 (2008)7697 of 26/11/2008
07/01/2009 Corrigendum
24/04/2009 Centralised - Variation EMEA/H/C/72/II/5 (2009)3188 of 22/04/2009
05/05/2009 Centralised - Variation EMEA/H/C/721/IA/10
10/05/2009 Centralised - Variation EMEA/H/C/721/IB/9
11/06/2009 Centralised - Variation EMEA/H/C/721/II/8
06/07/2009 Centralised - Variation EMEA/H/C/721/II/7
30/07/2009 Centralised - Variation EMEA/H/C/721/II/6 (2009)6069 of 24/07/2009
25/11/2009 Centralised - Variation EMEA/H/C/721/II/12, 13 (2009)9448 of 23/11/2009
06/01/2010 Centralised - Variation EMEA/H/C/721/II/14
04/06/2010 Centralised - Variation EMEA/H/C/721/II/15 (2010)3638 of 02/06/2010
10/08/2010 Centralised - Variation EMEA/H/C/721/II/11, 16, 17 (2010)5598 of 06/08/2010
24/02/2011 Centralised - Variation EMEA/H/C/721/IG/33/G
25/02/2011 Centralised - Variation EMEA/H/C/721/II/18, 19 (2011)1209 of 21/02/2011
18/03/2011 Centralised - Variation EMEA/H/C/721/IG/52/G
29/03/2011 Centralised - Variation EMEA/H/C/721/IG/51/G
27/04/2011 Centralised - Variation EMEA/H/C/721/IG/62/G
31/08/2011 Centralised - Variation EMEA/H/C/721/II/20 (2011)6232 of 26/08/2011
07/12/2011 Centralised - Variation EMEA/H/C/721/II/21, EMEA/H/C/721II/22 (2011)9180 of 05/12/2011
20/06/2012 Centralised - Variation EMEA/H/C/721/IA/39/G
Updated with Decision(2012)6527 of 17/09/2012
19/09/2012 Centralised - Renewal EMEA/H/C/721/R/35, EMEA/H/C/721/II/34 (2012)6527 of 17/09/2012
11/12/2012 Centralised - Variation EMEA/H/C/721/IB/43
Updated with Decision(2013)1973 of 27/03/2013
29/03/2013 Centralised - Variation EMEA/H/C/721/II/36 (2013)1973 of 27/03/2013
27/06/2013 Centralised - Variation EMEA/H/C/721/II/38
Updated with Decision(2013)9742 of 18/12/2013
23/12/2013 Centralised - Variation EMEA/H/C/721/II/48 (2013)9742 of 18/12/2013