Optison

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 its 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 27/06/2022

Authorisation details

Product details
Name
Optison
Agency product number
EMEA/H/C/000166
Active substance
perflutren
International non-proprietary name (INN) or common name
perflutren
Therapeutic area (MeSH)
Echocardiography
Anatomical therapeutic chemical (ATC) code
V08DA01
Publication details
Marketing-authorisation holder
GE Healthcare AS
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
17/05/1998
Contact address

Nycoveien 1
NO-0401 Oslo
Norway

Product information

19/05/2022 Optison - EMEA/H/C/000166 - N/0074

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

Contrast media

Therapeutic indication

This medicinal product is for diagnostic use only.

Optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left-ventricular-endocardial-border delineation with resulting improvement in wall-motion visualisation.

Optison should only be used in patients where the study without contrast enhancement is inconclusive.

Assessment history

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