EchoGen
Withdrawn
This medicine's authorisation has been withdrawn
dodecafluoropentane
Medicine
Human
Withdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 17 July 1998, the European Commission issued a Marketing Authorisation valid throughout the European Union for the medicinal product EchoGen, which contains dodecafluoropentane. The pharmaceutical company responsible for this medicinal product is Sonus Pharmaceuticals Ltd.
On 8 November 2000, the Marketing Authorisation Holder notified the European Commission of its decision to withdraw the Marketing Authorisation for EchoGen.
On 22 January 2001, the European Commission adopted the decision withdrawing the Marketing Authorisation for EchoGen. Pursuant to this decision the European Public Assessment report for EchoGen has been removed from the EMA website.
It should be noted that the product had never been marketed within the European Economic Area.
Product information
22/01/2001
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- EchoGen
- Active substance
- dodecafluoropentane
- International non-proprietary name (INN) or common name
- dodecafluoropentane
- Therapeutic area (MeSH)
- Echocardiography
- Anatomical therapeutic chemical (ATC) code
- V08DA
Pharmacotherapeutic group
Contrast mediaTherapeutic indication
EchoGen 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 border delineation with resulting improvement in wall motion visualisation.
EchoGen should only be used in patients where the study without contrast enhancement is inconclusive.
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