Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: M-M-RVAXPRO   
Auth. number : EU/1/06/337
Active substance : Measles, Mumps and Rubella 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: J07BD52 - Measles, combinations with mumps and rubella, live attenuated
(See WHO ATC Index)
Indication: M-M-RVAXPRO is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals from 12 months of age (see section 4.2).
M-M-RVAXPRO can be administered to infants from 9 months of age under special circumstances (see sections 4.2, 4.4 and 5.1).
For use in measles outbreaks, or for post-exposure vaccination, or, for use in previously unvaccinated individuals older than 9 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella, see section 5.1.
M-M-RVAXPRO is to be used on the basis of official recommendations.
Marketing Authorisation Holder: Sanofi Pasteur MSD SAS
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
11/05/2006 Centralised - Authorisation EMEA/H/C/604 (2006)1959 of 05/05/2006
01/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/IB/4
30/01/2007 Centralised - Notification EMEA/H/C/604/N/3
Updated with Decision(2007)1885 of 23/04/2007
25/04/2007 Centralised - Variation EMEA/H/C/604/II/5 (2007)1885 of 23/04/2007
22/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/IA/7
27/06/2007 Centralised - Variation EMEA/H/C/604/II/6 (2007)3181 of 25/06/2007
25/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/II/8
23/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/IA/10
23/04/2008 Centralised - Variation EMEA/H/C/604/II/12 (2008)1635 of 18/04/2008
24/06/2008 Centralised - Variation EMEA/H/C/604/II/11 (2008)3205 of 20/06/2008
24/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/II/13
20/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/II/14
22/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/II/15
30/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/IA/16
09/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/IA/17
05/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/II/19
21/01/2010 Centralised - Variation EMEA/H/C/604/II/20 (2010)343 of 19/01/2010
17/03/2010 Centralised - Variation EMEA/H/C/604/II/21 (2010)1808 of 15/03/2010
23/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/II/22
06/04/2010 Centralised - Variation EMEA/H/C/604/IA/23/G
Updated with Decision(2010)6241 of 06/09/2010
11/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/IA/25
22/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/WS/18
02/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/IB/26
09/09/2010 Centralised - Variation EMEA/H/C/604/II/24 (2010)6241 of 06/09/2010
28/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/WS/19/G
27/10/2010 Centralised - Variation EMEA/H/C/604/WS/44 (2010)7544 of 25/10/2010
17/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/604/IB/28/G
09/05/2011 Centralised - Renewal EMEA/H/C/604/R/27 (2011)3175 of 05/05/2011
16/04/2012 Centralised - Notification EMEA/H/C/604/N/43
Updated with Decision(2013)1095 of 20/02/2013
22/02/2013 Referral EMEA/H/C/604/A-20/45 (2013)1095 of 20/02/2013
01/07/2013 Centralised - Notification EMEA/H/C/604/N/52
Updated with Decision(2015)2468 of 09/04/2015
06/05/2014 Centralised - Variation EMEA/H/C/604/IG/435
Updated with Decision(2015)2468 of 09/04/2015
20/11/2014 Centralised - Variation EMEA/H/C/604/WS/492
Updated with Decision(2015)2468 of 09/04/2015
13/04/2015 Centralised - Yearly update (2015)2468 of 09/04/2015
28/05/2015 Centralised - Notification EMEA/H/C/604/N/69
21/12/2016 Centralised - Notification EMEA/H/C/604/N/81
11/01/2017 Centralised - Variation EMEA/H/C/IG/758
24/02/2017 Centralised - Variation EMEA/H/C/IG 777
24/03/2017 Centralised - Notification EMEA/H/C/604/N/84
18/05/2017 Centralised - Variation EMEA/H/C/604/II/80