Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: RotaTeq   
Auth. number : EU/1/06/348
INN : Rotavirus vaccine (live, oral)
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: J07BH02 - Rota virus, pentavalent, live, reassorted
(See WHO ATC Index)
Indication: Active immunisation of infants from the age of 6 weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection.RotaTeq is to be used on the basis of official recommendations.
Marketing Authorisation Holder: Sanofi Pasteur MSD, SNC
162 avenue Jean Jaurès, 69007 Lyon, France

  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
29/06/2006 Centralised - Authorisation EMEA/H/C/669 (2006)3044 of 27/06/2006
11/09/2006 Centralised - Variation EMEA/H/C/669/IA/2
19/09/2006 Centralised - Variation EMEA/H/C/669/IB/1
28/03/2007 Centralised - Variation EMEA/H/C/669/II/4
18/06/2007 Centralised - Variation EMEA/H/C/669/IA/6
Updated with Decision(2007)3641 of 24/07/2007
26/07/2007 Centralised - Variation EMEA/H/C/669/II/5 (2007)3641 of 24/07/2007
11/09/2007 Centralised - Variation EMEA/H/C/669/II/7 (2007)4232 of 07/09/2007
17/09/2007 Centralised - Variation EMEA/H/C/669/IB/8
13/12/2007 Centralised - Variation EMEA/H/C/669/II/10 (2007)6409 of 11/12/2007
18/12/2007 Centralised - Variation EMEA/H/C/669/II/9 (2007)6678 of 14/12/2007
25/05/2008 Centralised - Variation EMEA/H/C/669/II/11 (2008)1706 of 23/04/2008
01/10/2008 Centralised - Variation EMEA/H/C/669/II/14
30/10/2008 Centralised - Variation EMEA/H/C/669/II/12, 13 (2008)6491 of 28/10/2008
17/12/2008 Centralised - Variation EMEA/H/C/669/IA/18
17/12/2008 Centralised - Variation EMEA/H/C/669/IA/17
01/04/2009 Centralised - Variation EMEA/H/C/669/IA/19
02/07/2009 Centralised - Variation EMEA/H/C/669/II/15, 16 (2009)5330 of 29/06/2009
27/10/2009 Centralised - Variation EMEA/H/C/669/II/20 (2009)8394 of 23/10/2009
22/01/2010 Centralised - Variation EMEA/H/C/669/II/21 (2010)371 of 20/01/2010
01/04/2010 Centralised - Variation EMEA/H/C/669/II/22 (2010)2244 of 30/03/2010
06/04/2010 Centralised - Variation EMEA/H/C/669/IA/23/G
Updated with Decision(2010)5593 of 06/08/2010
10/08/2010 Centralised - Variation EMEA/H/C/669/II/24 (2010)5593 of 06/08/2010
17/01/2011 Centralised - Variation EMEA/H/C/669/IB/28
26/01/2011 Referral EMEA/H/C/669/A-20/25 (2011)405 of 21/01/2011
01/02/2011 Centralised - Variation EMEA/H/C/669/II/27 (2011)580 of 27/01/2011
03/03/2011 Centralised - Variation EMEA/H/C/669/II/26/G (2011)1484 of 28/02/2011
12/04/2011 Centralised - Variation EMEA/H/C/669/II/30 (2011)2626 of 08/04/2011
23/05/2011 Centralised - Renewal EMEA/H/C/669/R/29 (2011)3606 of 18/05/2011
24/02/2012 Centralised - Variation EMEA/H/C/669/II/31 (2012)1276 of 21/02/2012
26/10/2012 Centralised - Variation EMEA/H/C/669/II/39 (2012)7668 of 24/10/2012
16/02/2013 Centralised - Variation EMEA/H/C/669/IB/42
Updated with Decision(2014)564 of 29/01/2014
01/07/2013 Centralised - Variation EMEA/H/C/669/N/44
Updated with Decision(2014)564 of 29/01/2014
31/01/2014 Centralised - Variation (2014)564 of 29/01/2014
21/03/2014 Centralised - Variation EMEA/H/C/669/IB/51
06/05/2014 Centralised - Variation EMEA/H/C/669/IG/435