Is Perflutren approved by the US FDA?

Drugs@FDA lists 2 application product lines for Perflutren, including DEFINITY (Prescription); DEFINITY RT (Prescription).

Is Perflutren authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Perflutren: Optison, Luminity.

Are there safety signals or safety updates for Perflutren?

US FDA: 2 entries (latest 2024-03-01).

Active substance

Perflutren

US FDA 2
EMA 2
Health Canada 1
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
DEFINITY	13.04MG/2ML (6.52MG/ML)	injectable · intravenous	LANTHEUS MEDCL	Prescription	31 Jul 2001
DEFINITY RT	13.04MG/2ML (6.52MG/ML)	injectable · intravenous	LANTHEUS MEDCL	Prescription	31 Jul 2001

EMA European Union — centrally authorised medicines

Optison GE Healthcare AS · Authorised · authorised 17 May 1998 · ATC V08DA01

Therapeutic indication (EMA)

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.

Luminity Lantheus EU Limited · Authorised · authorised 20 Sep 2006 · ATC V08DA04

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DEFINITY	02243173	150 MCL / ML	SUSPENSION · INTRAVENOUS	LANTHEUS MI CANADA INC

Safety signals and safety-related labeling changes

US FDA 1 Mar 2024 DEFINITY — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 1 Mar 2024 DEFINITY RT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations

All safety entries for perflutren →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.