Synagis

RSS

palivizumab

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 22/03/2023

Authorisation details

Product details
Name
Synagis
Agency product number
EMEA/H/C/000257
Active substance
palivizumab
International non-proprietary name (INN) or common name
palivizumab
Therapeutic area (MeSH)
Respiratory Syncytial Virus Infections
Anatomical therapeutic chemical (ATC) code
J06BD01
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
45
Date of issue of marketing authorisation valid throughout the European Union
13/08/1999
Contact address

AstraZeneca AB
Sodertalje
SE-151 85 Sodertalje
Sweden

Product information

13/07/2022 Synagis - EMEA/H/C/000257 - IA/0128

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Immune sera and immunoglobulins

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.

Assessment history

Changes since initial authorisation of medicine

Related content

How useful was this page?

Add your rating
Average
1 rating
1 rating