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 31/05/2018

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
J06BB16
Publication details
Marketing-authorisation holder
AbbVie Deutschland GmbH Co. KG
Revision
39
Date of issue of marketing authorisation valid throughout the European Union
12/08/1999
Contact address
Knollstrasse
67061 Ludwigshafen
Germany

Product information

08/05/2018 Synagis - EMEA/H/C/000257 - T/0116

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

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