GE Healthcare said it has applied to the European Medicines Agency (EMA) to amend its marketing authorization to allow the company to manufacture its Optison echocardiography contrast agent at its own facility in Norway.
If approved, the company will supply Optison 0.19 mg/mL dispersion for injection to the European Union market from the manufacturing facility in Oslo, GE said. The additional manufacturing facility will allow the firm to increase capacity to meet market demand in the EU.
