METARAMINOL PHEBRA, ARAMINE (Phebra Pty Ltd)
Product name
METARAMINOL PHEBRA, ARAMINE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
129 working days (255)
Active ingredients
metaraminol (as tartrate)
Registration type
New generic medicine
Indication
METARAMINOL PHEBRA, ARAMINE (injection) is indicated for the prevention and treatment of the acute hypotensive state occurring with spinal anaesthesia; adjunctive treatment of hypotension due to haemorrhage, reactions to medications, surgical complications, and shock associated with brain damage due to tumour or trauma. They may also be useful as an adjunct in the treatment of hypotension due to cardiogenic shock or septicaemia.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine