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.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
J06BD01
ATC Item
palivizumab
Pharmacotherapeutic Group
Immune sera and immunoglobulins
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| palivizumab | N/A | Palivizumab |
EMA Name
Synagis
Medicine Name
Synagis
Aliases
N/A
