Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Rotarix   
Auth. number : EU/1/05/330
INN : Rotavirus vaccine, live
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BH - Rota virus diarrhea vaccines
Chemical substance: J07BH01 - Rota virus, live attenuated
(See WHO ATC Index)
Indication: Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastro-enteritis due to rotavirus infection.
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
23/02/2006 Centralised - Authorisation EMEA/H/C/639 (2006)602 of 21/02/2006
05/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/IA/2
05/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/IA/3
01/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/II/4
13/12/2006 Centralised - Variation EMEA/H/C/639/II/1 (2006)6736 of 11/12/2006
06/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/II/6
07/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/II/7
25/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/II/9
10/12/2007 Centralised - Variation EMEA/H/C/639/II/11 (2007)6270 of 06/12/2007
05/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/IA/14
23/06/2008 Centralised - Variation EMEA/H/C/639/II/13 (2008)3091 of 19/06/2008
08/07/2008 Centralised - Variation EMEA/H/C/639/II/12 (2008)3535 of 04/07/2008
03/09/2008 Centralised - Variation EMEA/H/C/639/X/10 (2008)4822 of 01/09/2008
01/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/II/15
24/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/II/16
30/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/II/19
25/08/2009 Centralised - Variation EMEA/H/C/639/II/17, 18 (2009)6623 of 21/08/2009
04/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/II/22
25/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/IA/23
11/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/II/21
01/04/2010 Centralised - Variation EMEA/H/C/639/II/20 (2010)2259 of 30/03/2010
28/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/II/27
05/10/2010 Referral EMEA/H/C/639/A-20 (2010)6910 of 30/09/2010
08/11/2010 Centralised - Variation EMEA/H/C/639/II/25 (2010)7722 of 03/11/2010
27/01/2011 Centralised - Renewal EMEA/H/C/639/R/28 (2011)454 of 24/01/2011
24/02/2011 Centralised - Variation (refusal) EMEA/H/C/639/IG/33/G
18/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/639/IG/52/G
18/04/2011 Centralised - Variation EMEA/H/C/639/II/26 (2011)2794 of 14/04/2011
11/05/2011 Centralised - Variation EMEA/H/C/639/II/30 (2011)3241 of 06/05/2011
12/05/2011 Centralised - Variation EMEA/H/C/639/II/30 (2011)3240 of 06/05/2011
20/05/2011 Centralised - Variation EMEA/H/C/639/II/29/G (2011)3603 of 18/05/2011
26/10/2011 Centralised - Variation EMEA/H/C/639/II/32 (2011)7782 of 24/10/2011
21/11/2012 Centralised - Variation EMEA/H/C/639/IB/45
Updated with Decision(2013)8332 of 20/11/2013
25/07/2013 Centralised - Variation EMEA/H/C/639/II/47
Updated with Decision(2013)8332 of 20/11/2013
22/11/2013 Centralised - Yearly update (2013)8332 of 20/11/2013
18/04/2014 Centralised - Variation EMEA/H/C/639/IB/66