The marketing authorization application (MAA) for Cleviprex was submitted via the decentralized procedure, with the UK acting as the reference member state.
Concerned member states participating in the review are Austria, Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Spain and Sweden. The Medicines Company anticipates making Cleviprex available in the European Union in 2010.
John Kelley, president and COO of The Medicines Company, said: “This regulatory submission is another step in our corporate strategy to build a leading global critical care medicines business that offers valuable, safe and effective medicines. If approved, Cleviprex will provide European physicians with an effective tool that could advance the management of blood pressure in the surgical and critical care settings.”