Luminity

RSS

perflutren

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 21/06/2018

Authorisation details

Product details
Name
Luminity
Agency product number
EMEA/H/C/000654
Active substance
perflutren
International non-proprietary name (INN) or common name
perflutren
Therapeutic area (MeSH)
Echocardiography
Anatomical therapeutic chemical (ATC) code
V08DA04
Publication details
Marketing-authorisation holder
Lantheus MI UK Ltd.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
20/09/2006
Contact address
Festival House. 39 Oxford Street
Newbury
Berkshire RG14 1JG
United Kingdom

Product information

04/05/2018 Luminity - EMEA/H/C/000654 - N/0025

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

CONTRAST MEDIA

Therapeutic indication

This medicinal product is for diagnostic use only.

Luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.

Assessment history

How useful was this page?

Add your rating