Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 01 June 2018

Indication(s)

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 6 months of age at the onset of the RSV season.
- Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
- Children less than 2 years of age and with haemodynamically significant congenital heart disease.

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Category Value
Agency product number EMEA/H/C/000257
Orphan designation No
Date First Approved 13-08-1999
Type Medicinal product subject to medical prescription
Marketing authorisation holder AbbVie Deutschland GmbH & Co. KG