Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 06 December 2017

Indication(s)

Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.

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Category Value
Agency product number EMEA/H/C/000549
Orphan designation No
Date First Approved 29-07-2004
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Orphan Europe S.A.R.L.