Committee for Orphan Medicinal Products: Public summary of positive opinion for orphan designation of ibuprofen for the prevention of patent ductus arteriosus in premature neonates of less than 34 weeks of gestational age.

On 5 Mar 2001, orphan designation (EU/3/01/027) was granted by the European Commission to Orphan Europe, France, for ibuprofen for the prevention of patent ductus arteriosus in premature neonates of less than 34 weeks of gestational age. On 15 May 2009, the European Medicines Agency's (EMEA) Committee for Orphan Medicinal Products (COMP) published a public summary of positive opinion for orphan designation of ibuprofen for the prevention of patent ductus arteriosus in premature neonates of less than 34 weeks of gestational age. There are questions and answers covering: What is patent ductus arteriosus?, What is the estimated number of patients affected by the condition?, What methods of …