🇪🇺 MEDI-493 in European Union

EMA authorised MEDI-493 on 13 August 1999

Marketing authorisation

EMA — authorised 13 August 1999

  • Application: EMEA/H/C/000257
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Synagis
  • 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.
  • Status: approved

Read official source →

Frequently asked questions

Is MEDI-493 approved in European Union?

Yes. EMA authorised it on 13 August 1999.

Who is the marketing authorisation holder for MEDI-493 in European Union?

AstraZeneca AB holds the EU marketing authorisation.