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NEUPEDIX (Waymade Australia Pty Limited)

Product name
NEUPEDIX
Date registered
Evaluation commenced
Decision date
Approval time
111 (175 working days)
Active ingredients
Alprostadil
Registration type
New generic medicine
Indication

NEUPEDIX is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon a patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, mitral atresia, or transposition of the great vessels with or without other defects.