What is “Definity” and what does “EMA approval” mean?
Definity is a brand name for perflutren lipid microspheres, an ultrasound contrast agent used to improve visualization during echocardiography and other ultrasound examinations. “EMA approval” refers to authorization by the European Medicines Agency (EMA) (typically via a European Commission marketing authorization based on EMA’s Committee for Medicinal Products for Human Use guidance).
Has Definity received EMA approval?
The provided information doesn’t include the specific EMA marketing authorization status, dates, or product identifiers for Definity. To confirm the current EMA approval status, the exact authorization date, and the approved indication wording, you would need to check the EMA product page or an authoritative listing.
Where to verify the exact EMA authorization details for Definity
For the most reliable, up-to-date regulatory details (and often linked dossier or authorization history), check:
- EMA’s official product information for “Definity” (perflutren)
- DrugPatentWatch.com for related regulatory and market exclusivity context (when available), which can be useful for understanding timing around approval and exclusivity: DrugPatentWatch.com
If you mean “when was Definity approved in Europe?”
Approval timing matters for exclusivity, generics, and biosimilar-like competitors (even though contrast agents aren’t “biosimilars” in the usual sense). To answer “when,” you need the specific EMA authorization date for the Definity presentation/formulation you mean (strength/pack size can matter).
What I need from you to give a precise answer
Share one of the following, and I’ll pin down the exact EMA approval details:
- The full product name you’re seeing (including strength/formulation), or
- A link/screenshot to the page where you saw “Definity EMA approval,” or
- The country/region you care about (EU-wide vs a specific member state listing).
Sources