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
|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||
18/03/2021 Synagis - EMEA/H/C/000257 - T/0124
- 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
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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.