M-M-RVAXPRO

measles, mumps and rubella vaccine (live)

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is M-M-RVAXPRO?

M-M-RVAXPRO is a vaccine that contains live attenuated (weakened) measles, mumps and rubella viruses. It is available as a powder and solvent that are made up into a suspension for injection.

What is M-M-RVAXPRO used for?

M-M-RVAXPRO is used to vaccinate against measles, mumps, and rubella (German measles) in adults and children aged 12 months or older. Under some special circumstances, it can also be used in babies as young as nine months.

The vaccine can only be obtained with a prescription.

How is M-M-RVAXPRO used?

M-M-RVAXPRO is given according to official recommendations. It is given as one dose injected into a muscle or under the skin, preferably in the thighs of younger children and around the shoulder in older children and adults. For people with thrombocytopenia (low blood platelet counts) or any problems with blood clotting, the vaccine should only be injected under the skin to avoid bleeding. People who did not respond to the first dose can be given a second dose after at least four weeks.

Babies between nine and 12 months can be given the vaccine if they are considered to be at special risk, for example, if there is an outbreak in a day-care or the baby is travelling to an area where measles is common. They should be re-vaccinated at between 12 and 15 months. They may also be given an additional vaccination against measles.

How does M-M-RVAXPRO work?

M-M-RVAXPRO is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. M-M-RVAXPRO contains small amounts of weakened forms of the viruses that cause measles, mumps, and rubella. When a person is given the vaccine, the immune system recognises the weakened viruses as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these viruses. This will help to protect against diseases caused by these viruses.

M-M-RVAXPRO is very similar to another vaccine for the measles, mumps and rubella vaccine already authorised (M-M-R II) but with a slight difference. Both vaccines contain very small amounts of a protein (albumin) that is used in the manufacturing process. While the albumin in M-M-R-II is extracted from human blood, the albumin in M-M-RVAXPRO is obtained using ‘recombinant DNA technology’ (a technique where a yeast is given a gene (DNA) that makes it able to produce the protein).

How has M-M-RVAXPRO been studied?

Three main studies were carried out with M-M-RVAXPRO. The first study, which involved 1,279 children, compared M-M-RVAXPRO with a similar vaccine that used albumin from human blood in its production. This study looked at the ability of the vaccine when injected under the skin, to trigger the production of antibodies against the viruses (‘immunogenicity’). A second study in 1,997 children looked specifically at mumps, to see if M-M-RVAXPRO when injected under the skin provided enough protection against the disease. A third study in 776 children compared the effects of M-M-RVAXPRO when given as injected into the muscle and when injected under the skin.

A fourth study was carried out with ProQuad (a vaccine that contains similar weakened viruses to those of M-M-RVAXPRO) given as two doses. The study compared the immune response of babies aged nine or 11 months at the time of the first dose with that of babies aged 12 months. A total of 1,620 babies took part in this study.

What benefit has M-M-RVAXPRO shown during the studies?

In the first study, M-M-RVAXPRO triggered the same level of immune response as the comparator. For both vaccines, the proportion of patients with a sufficient amount of antibodies against the three viruses was around 98% or higher. The second study also showed that M-M-RVAXPRO triggered the production of sufficient amounts of antibodies against mumps. The third study showed that the immune response triggered by M-M-RVAXPRO was the same regardless of whether it was injected into a muscle or under the skin. The fourth study showed that, after the second dose, the production of antibodies against mumps, and rubella was similar among babies who started vaccination at nine, 11 and 12 months. However, the immune response for measles was lower in babies who started vaccination at nine months.

What is the risk associated with M-M-RVAXPRO?

The most common side effects with M-M-RVAXPRO (seen in more than 1 patient in 10) are fever (38.5°C or higher), and injection-site redness, pain and swelling. Injection-site reactions were less common when the vaccine was injected into a muscle. For the full list of all side effects reported with M-M-RVAXPRO, see the package leaflet.

M-M-RVAXPRO should not be used in people who may be hypersensitive (allergic) to any measles, mumps or rubella vaccine, or to any of the ingredients, including neomycin (an antibiotic). M-M-RVAXPRO must not be given during pregnancy, any illness with fever (over 38.5°C) or active untreated tuberculosis (TB). It must also not be given to patients with certain blood or immune diseases. For the full list of restrictions, see the package leaflet.

Why has M-M-RVAXPRO been approved?

The CHMP decided that M-M-RVAXPRO’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of M-M-RVAXPRO?

The company that makes M-M-RVAXPRO will continue to monitor the side effects to see if using recombinant albumin in the manufacturing process of M-M-RVAXPRO leads to side effects such as allergic reactions.

Other information about M-M-RVAXPRO

The European Commission granted a marketing authorisation valid throughout the European Union for M-M-RVAXPRO to Sanofi Pasteur MSD SNC on 5 May 2006. The marketing authorisation is valid for an unlimited period.

Name Language First published Last updated
M-M-RVAXPRO : EPAR - Summary for the public BG = bălgarski 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public ES = español 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public CS = čeština 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public DA = dansk 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public DE = Deutsch 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public ET = eesti keel 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public EL = elliniká 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public EN = English 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public FR = français 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public IT = italiano 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public LV = latviešu valoda 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public LT = lietuvių kalba 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public HU = magyar 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public MT = Malti 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public NL = Nederlands 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public PL = polski 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public PT = português 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public RO = română 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public SK = slovenčina 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public SL = slovenščina 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public FI = suomi 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public SV = svenska 09/08/2006 18/08/2011
M-M-RVAXPRO : EPAR - Summary for the public HR = Hrvatski 09/08/2006 18/08/2011

This EPAR was last updated on 11/08/2015 .

Authorisation details

Product details

Product details for M-M-RVAXPRO
NameM-M-RVAXPRO
Agency product numberEMEA/H/C/000604
Active substance

measles virus Enders’ Edmonston strain (live, attenuated) / mumps virus Jeryl Lynn (level B) strain (live, attenuated) / rubella virus Wistar RA 27/3 strain (live, attenuated)

International non-proprietary name (INN) or common name

measles, mumps and rubella vaccine (live)

Therapeutic area MumpsRubellaImmunizationMeasles
Anatomical therapeutic chemical (ATC) code J07BD52

Publication details

Publication details for M-M-RVAXPRO
Marketing-authorisation holder

Sanofi Pasteur MSD SNC

Revision15
Date of issue of marketing authorisation valid throughout the European Union05/05/2006

Contact address:

Sanofi Pasteur MSD SNC
162 avenue Jean Jaurès
69007 Lyon
France 

Product information

Product information

27/05/2015  M-M-RVAXPRO -EMEA/H/C/000604 -N/0069

Name Language First published Last updated
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015
M-M-RVAXPRO : EPAR - Product Information HR = Hrvatski 04/08/2008 11/08/2015

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014
M-M-RVAXPRO : EPAR - All Authorised presentations HR = Hrvatski 09/08/2006 13/05/2014

Pharmacotherapeutic group

Vaccines

Therapeutic indication

M-M-RVAXPRO is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months or older.

For use in measles outbreaks, or for post-exposure vaccination, or for use in previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
M-M-RVAXPRO : EPAR - Procedural steps taken before authorisation HR = Hrvatski 09/08/2006  
M-M-RVAXPRO : EPAR - Scientific Discussion HR = Hrvatski 09/08/2006  

Authorised

This medicine is approved for use in the European Union

More information on M-M-RVAXPRO