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 : EPAR - Summary for the public (PDF/93.97 KB)
First published: 11/09/2009
Last updated: 18/12/2013
Synagis : EPAR - Risk Management Plan (PDF/1.03 MB)
First published: 22/03/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Respiratory Syncytial Virus Infections
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
14/09/2023 Synagis - EMEA/H/C/000257 - II/0132
This medicine’s product information is available in all official EU languages.
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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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Immune sera and immunoglobulins
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.