Synagis (palivizumab)
- Region
- 🇪🇺 EU
- Active substance
- palivizumab
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- Respiratory Syncytial Virus Infections
- CHMP opinion
- Wed 19 May 1999
- EU approval
- Fri 13 Aug 1999
- Application
- EMEA/H/C/000257
- ATC
- J06BD01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.