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 their 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 against measles, mumps, and rubella (German measles). It is a powder and solvent to be made up into a suspension for injection. The active substances are attenuated (weakened) viruses for the diseases .

What is M-M-RVAXPRO used for?

M-M-RVAXPRO is used to vaccinate against measles, mumps, and rubella, individuals 12 months or older. The medicine can only be obtained with a prescription.

How is M-M-RVAXPRO used?

M-M-RVAXPRO is given by a doctor or nurse who will inject the suspension subcutaneously (just under the skin) into the upper arm or thigh. Individuals 12 months or older should receive one dose. A second dose may be given at least 4 weeks after the first dose. The second dose is intended for people
who did not respond to the first dose for any reason. There is no information on the safety and effectiveness of M-M-RVAXPRO in infants below 12 months.

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 quicker when it is again exposed to the viruses. The antibodies will help to protect against diseases caused by these viruses.

M-M-RVAXPRO is very similar to another presentation of the measles, mumps and rubella vaccine already authorised (M-M-R II) but with a slight difference: where the existing presentation is manufactured with a protein, albumin, that is extracted from human serum (the liquid part of the blood); M-M-RVAXPRO is manufactured with the same protein, but made using ‘recombinant DNA technology’ (a technique where a yeast is given a gene (DNA) that makes it able to produce human albumin).

How has M-M-RVAXPRO been studied?

The study for M-M-RVAXPRO compared its effectiveness to that of the previous presentation of the measles, mumps and rubella vaccine in 1,279 children. The study measured the ability of the vaccine to make the immune system respond to the viruses. Another study in a further 1,997 children looked more specifically at one of the component of the vaccine (mumps) to show that the level used in M-M-RVAXPRO provides enough protection against the disease.

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

M-M-RVAXPRO provided the same level of immune response as the measles, mumps, and rubella vaccine containing serum albumin. The response rates (measuring how the immune system had responded to the viruses) were: 98.3% for measles, 99.4% for mumps and 99.6% for rubella.

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

The most common side effects in children who were given M-M-RVAXPRO were fever (38.5°C or higher), and injection site reactions (redness, pain, swelling). For the full list of all side effects reported with M-M-VAXPRO, please 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 should not be given during pregnancy, an illness with fever (over 38.5°C), active untreated tuberculosis (TB), or when the patient has any disease that affects their immune system. For the full list of restrictions, see the Package Leaflet.

Why has M-M-RVAXPRO been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that M-M-RVAXPRO’s benefits are greater than its risks for the combined vaccination against measles, mumps, and rubella in individuals 12 months or older. They recommended that M-M-RVAXPRO 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.

This EPAR was last updated on 18/08/2011 .

More detail is available in the Summary of Product Characteristics

Product details

Publication details

Product information

05/05/2011  M-M-RVAXPRO -EMEA/H/C/000604 -R/0027

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.

Pharmaco-therapeutic 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.

Changes since initial authorisation of medicine

Initial Marketing authorisation documents