Basic Information
Pedea
Regulatory Information
EMEA/H/C/000549
July 28, 2004
18
December 12, 2024
Company Information
France
Tour Hekla 52 Avenue Du General De Gaulle 92800 Puteaux
RECORDATI RARE DISEASES
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Overview Summary
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine. If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).