Ibuprofen Gen.Orph is a medicine used to treat ‘patent ductus arteriosus’ in newborn premature babies who were born six or more weeks too early (less than 34 weeks gestational age). Patent ductus arteriosus is a condition where the ductus arteriosus (the blood vessel that allows blood to bypass the baby’s lungs before birth) fails to close after birth. This causes heart and lung problems in the baby. Ibuprofen Gen.Orph is a ‘generic medicine’. This means that Ibuprofen Gen.Orph contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Ibuprofen Gen.Orph is Pedea. For more information on generic medicines, see the question\-and\-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf). Ibuprofen Gen.Orph contains the active substance ibuprofen.
Therapeutic Indication
Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age
Therapeutic Area (MeSH)
ATC Code
C01EB16
ATC Item
N/A
Pharmacotherapeutic Group
Other cardiac preparations
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Ibuprofen | N/A | Ibuprofen |
EMA Name
Ibuprofen Gen.Orph
Medicine Name
Ibuprofen Gen.Orph
Aliases
N/ANo risk management plan link.