Synagis

palivizumab

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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.

What is Synagis?

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

What is Synagis used for?

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.

How is Synagis used?

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.

How does Synagis work?

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.

How has Synagis been studied?

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.

What benefit has Synagis shown during the studies?

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%.

What is the risk associated with Synagis?

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.

Why has Synagis been approved?

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

Other information about Synagis:

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.

Name Language First published Last updated
Synagis : EPAR - Summary for the public BG = bălgarski 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public ES = español 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public CS = čeština 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public DA = dansk 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public DE = Deutsch 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public ET = eesti keel 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public EL = elliniká 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public EN = English 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public FR = français 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public IT = italiano 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public LV = latviešu valoda 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public LT = lietuvių kalba 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public HU = magyar 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public MT = Malti 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public NL = Nederlands 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public PL = polski 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public PT = português 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public RO = română 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public SK = slovenčina 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public SL = slovenščina 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public FI = suomi 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public SV = svenska 11/09/2009 18/12/2013
Synagis : EPAR - Summary for the public HR = Hrvatski 11/09/2009 18/12/2013

This EPAR was last updated on 23/06/2016 .

Authorisation details

Product details

Product details for Synagis
NameSynagis
Agency product numberEMEA/H/C/000257
Active substance

palivizumab

International non-proprietary name (INN) or common name

palivizumab

Therapeutic area Respiratory Syncytial Virus Infections
Anatomical therapeutic chemical (ATC) code J06BB16

Publication details

Publication details for Synagis
Marketing-authorisation holder

AbbVie Ltd
 

Revision33
Date of issue of marketing authorisation valid throughout the European Union13/08/1999

Contact address:

AbbVie Ltd
Maidenhead
SL6 4UB
United Kingdom

Product information

Product information

22/01/2016  Synagis -EMEA/H/C/000257 -N/0110

Name Language First published Last updated
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016
Synagis : EPAR - Product Information HR = Hrvatski 04/12/2009 03/02/2016

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
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014
Synagis : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 15/09/2014

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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Synagis : EPAR - Procedural steps taken before authorisation HR = Hrvatski 21/10/2005  
Synagis : EPAR - Scientific Discussion HR = Hrvatski 21/10/2005  

Authorised

This medicine is approved for use in the European Union