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EMA Product

Optison

Product approved by European Medicines Agency (EU)

Basic Information

Optison

Regulatory Information

EMEA/H/C/000166

Authorised

May 17, 1998

19

June 27, 2022

Company Information

Norway

Nycoveien 1 NO-0401 Oslo

GE Healthcare AS

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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).

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