🇪🇺 Optison in European Union

EMA authorised Optison on 17 May 1998

Marketing authorisation

EMA — authorised 17 May 1998

  • Application: EMEA/H/C/000166
  • Marketing authorisation holder: GE Healthcare AS
  • Local brand name: Optison
  • 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.
  • Status: approved

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Optison in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in European Union

Frequently asked questions

Is Optison approved in European Union?

Yes. EMA authorised it on 17 May 1998.

Who is the marketing authorisation holder for Optison in European Union?

GE Healthcare AS holds the EU marketing authorisation.