Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: ProQuad   
Auth. number : EU/1/05/323
INN : Measles, Mumps, Rubella and Varicella Vaccine (Live)
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BD - Measles vaccines
Chemical substance: J07BD54 - Measles, combinations with mumps, rubella and varicella, live attenuated
(See WHO ATC Index)
Indication: ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age.ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles).
Marketing Authorisation Holder: Sanofi Pasteur MSD, SNC
8 rue Jonas Salk, F-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
10/04/2006 Centralised - Authorisation EMEA/H/C/622 (2006)1565 of 06/04/2006
09/06/2006 Centralised - Variation EMEA/H/C/622/IA/2
Updated with Decision(2006)4163 of 12/09/2006
09/06/2006 Centralised - Variation EMEA/H/C/622/IA/3
14/09/2006 Centralised - Variation EMEA/H/C/622/II/1 (2006)4163 of 12/09/2006
31/01/2007 Centralised - Variation EMEA/H/C/622/IB/4
26/03/2007 Centralised - Variation EMEA/H/C/622/II/5
22/05/2007 Centralised - Variation EMEA/H/C/622/IA/6
25/09/2007 Centralised - Variation EMEA/H/C/622/II/7
22/10/2007 Centralised - Variation EMEA/H/C/622/IB/9
23/01/2008 Centralised - Variation EMEA/H/C/622/IA/11
24/06/2008 Centralised - Variation EMEA/H/C/622/II/12 (2008)3195 of 20/06/2008
27/03/2009 Centralised - Variation EMEA/H/C/622/IA/20
27/03/2009 Centralised - Variation EMEA/H/C/622/II/17 (2009)2298 of 25/03/2009
30/03/2009 Centralised - Variation EMEA/H/C/622/IA/20
29/05/2009 Centralised - Variation EMEA/H/C/622/IB/21
09/06/2009 Centralised - Variation EMEA/H/C/622/IA/22
03/07/2009 Centralised - Variation EMEA/H/C/622/II/18 (2009)5404 of 01/07/2009
07/07/2009 Centralised - Variation EMEA/H/C/622/IA/23
05/01/2010 Centralised - Variation EMEA/H/C/622/I/25
21/01/2010 Centralised - Variation EMEA/H/C/622/II/26 (2010)346 of 19/01/2010
23/02/2010 Centralised - Variation EMEA/H/C/622/II/27
23/03/2010 Centralised - Variation EMEA/H/C/622/II/28
06/04/2010 Centralised - Variation EMEA/H/C/622/IA/29/G
Updated with Decision(2010)6244 of 06/09/2010
03/05/2010 Centralised - Variation EMEA/H/C/622/IA/30
22/07/2010 Centralised - Variation EMEA/H/C/622/WS/18
02/09/2010 Centralised - Variation EMEA/H/C/622/IB/32
09/09/2010 Centralised - Variation EMEA/H/C/622/II/31 (2010)6244 of 06/09/2010
28/09/2010 Centralised - Variation EMEA/H/C/622/WS/17/G
28/09/2010 Centralised - Variation EMEA/H/C/622/WS/19/G
07/10/2010 Centralised - Variation EMEA/H/C/622/IB/35
27/10/2010 Centralised - Variation EMEA/H/C/622/WS/44 (2010)7545 of 25/10/2010
25/11/2010 Centralised - Variation EMEA/H/C/622/II/36
17/12/2010 Centralised - Variation EMEA/H/C/622/IB/38
15/02/2011 Centralised - Variation EMEA/H/C/622/IB/39/G
24/02/2011 Centralised - Variation EMEA/H/C/622/WS/99/G
02/03/2011 Centralised - Variation EMEA/H/C/622/II/37/G (2011)1473 of 28/02/2011
22/03/2011 Centralised - Renewal EMEA/H/C/622/R/34 (2011)1894 of 17/03/2011
07/09/2011 Centralised - Variation EMEA/H/C/622/II/41 (2011)6370 of 05/09/2011
24/02/2012 Centralised - Variation EMEA/H/C/622/II/53, 54 (2012)1273 of 21/02/2012
21/03/2012 Centralised - Variation EMEA/H/C/622/II/56 (2012)1919 of 19/03/2012
26/04/2012 Centralised - Variation EMEA/H/C/622/II/55 (2012)2863 of 20/04/2012
20/02/2013 Referral EMEA/H/C/622/A-20/60 (2013)1014 of 18/02/2013
02/08/2013 Centralised - Variation EMEA/H/C/622/X/68 (2013)5140 of 31/07/2013
20/12/2013 Centralised - Variation EMEA/H/C/622/WS/438 (2013)9727 of 18/12/2013
23/01/2014 Centralised - Variation EMEA/H/C/622/II/73/G
25/04/2014 Centralised - Variation EMEA/H/C/622/II/78G
06/05/2014 Centralised - Variation EMEA/H/C/622/IG/435