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SonoVue® Reports Integrated WWM&RA Advisory Committee Briefing Document SonoVue® (sulfur hexafluoride microbubbles)
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City

Document / /

Company

AEs / Bracco Diagnostics Inc. / Clinical Safety Experience Bracco Diagnostics Inc. / /

Continent

Asia / Europe / /

Country

Switzerland / Romania / Hungary / Estonia / Slovenia / Bulgaria / Cyprus / Latvia / Poland / Norway / United States / Iceland / Canada / Slovakia / Malta / China / Singapore / Lithuania / South Korea / India / Czech Republic / /

Event

FDA Phase / /

IndustryTerm

intravascular imaging agents / cardiac and noncardiac applications / low solubility gas / literature search / /

MedicalCondition

pulmonary route / Documented Coronary Artery Disease / COPD / chest pain / headache / acute myocardial infarctions / nausea / anaphylaxis / Fatigue / Diffuse Interstitial Pulmonary Fibrosis / hypersensitivity / cardiovascular diseases / Congestive Heart Failure / hypertension / flushing / pulmonary hemodynamics / dyspnea / apparent hypersensitivity / pulmonary function / Chronic Obstructive Pulmonary Disease / cardiovascular disease / Pulmonary Hypertension / serious hypersensitivity / pain / dizziness flushing / myocardial infarction / coronary artery disease / dizziness / back pain nausea/vomiting / severe chronic obstructive pulmonary disease / /

MedicalTreatment

heart catheterization / /

Organization

Food and Drug Administration / Commission of the European Communities / Drug Safety and Risk Management Advisory Committee / SonoVue administration / European Union / Advisory Committee / Cardiovascular and Renal Drugs Advisory Committee / /

Position

physician / Executive / /

Product

Microspheres Injectable suspension / Optison / Definity / USCAs / SonoVue / Europe / /

Technology

Ultrasound / pharmacokinetics / CAD / Medical Imaging / /

URL

www.fda.gov/ohrms/dockets/AC/08/briefing/2008-4369b105.pdf / http /

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