Luminity
perflutren
Table of contents
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).
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 EU Limited
|
Revision |
14
|
Date of issue of marketing authorisation valid throughout the European Union |
20/09/2006
|
Contact address |
Product information
10/09/2020 Luminity - EMEA/H/C/000654 - II/0033
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.