Overview

This is a summary of the European public assessment report (EPAR) for Synagis. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Synagis.

Synagis is a powder and solvent that are made up into a solution for injection. It contains the active substance palivizumab.

Synagis is used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) that would require hospitalisation. It is used in the following groups of children, who are at high risk for this disease:

  • children who are less than six months old and were born five or more weeks prematurely (at 35 weeks gestation or less);
  • children who are less than two years of age and have had treatment for bronchopulmonary dysplasia (abnormal lung tissue, usually seen in babies born prematurely) within the last six months;
  • children who are less than two years of age and were born with a serious heart disease.

The medicine can only be obtained with a prescription.

Synagis is given once a month when there is a risk of RSV infection in the community: in the northern hemisphere, this is from November to April. If possible, the first dose should be given before this season starts. Patients generally receive a total of five monthly injections into the thigh muscle.

The active substance in Synagis, palivizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen). Palivizumab has been designed to attach to a protein called ‘fusion protein A’ on the surface of RSV. When palivizumab is attached to this protein, the virus becomes unable to enter the body’s cells, especially those in the lungs. This helps to prevent RSV infection.

The main study of Synagis was carried out in 1,502 high-risk children and compared Synagis with placebo (a dummy treatment) during one RSV season. Another study was also carried out comparing Synagis with placebo in 1,287 children who were born with heart disease. In both studies, the main measure of effectiveness was the number of children who had to be admitted to hospital because of RSV infection.The effects of Synagis were first tested in experimental models before being studied in humans.

Synagis was more effective than placebo in reducing RSV-related hospitalisations: 5% of the children who received Synagis were admitted to hospital for RSV infection during the study, compared with 11% of those who received placebo. This was a reduction of 55%. In children born with heart disease, there was a reduction of 45%.

The most common side effects with Synagis (seen in between 1 and 10 patients in 100) are fever and rash. For the full list of all side effects reported with Synagis, see the package leaflet.

Synagis must not be used in people who are hypersensitive (allergic) to palivizumab, any of the other ingredients or other ‘humanised’ monoclonal antibodies.

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

The European Commission granted a marketing authorisation valid throughout the European Union for Synagis on 13 August 1999.

For more information about treatment with Synagis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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Product information

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Latest procedure affecting product information: II/0132

14/09/2023

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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Product details

Name of medicine
Synagis
Active substance
palivizumab
International non-proprietary name (INN) or common name
palivizumab
Therapeutic area (MeSH)
Respiratory Syncytial Virus Infections
Anatomical therapeutic chemical (ATC) code
J06BD01

Pharmacotherapeutic group

Immune sera and immunoglobulins

Therapeutic indication

Synagis is indicated for the prevention of serious lower-respiratory-tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease:

  • children born at 35 weeks of gestation or less and less than six months of age at the onset of the RSV season;
  • children less than two years of age and requiring treatment for bronchopulmonary dysplasia within the last six months;
  • children less than two years of age and with haemodynamically significant congenital heart disease.

Authorisation details

EMA product number
EMEA/H/C/000257
Marketing authorisation holder
AstraZeneca AB

SE-151 85 Sodertalje
Sweden

Opinion adopted
19/05/1999
Marketing authorisation issued
13/08/1999
Revision
46

Assessment history

Topics

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