ATRACURIUM BESILATE MEDSURGE/ ATRACURIUM BESILATE MEDICIANZ (Medsurge Pharma Pty Ltd)
Product name
ATRACURIUM BESILATE MEDSURGE/ ATRACURIUM BESILATE MEDICIANZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
122 (255 working days)
Active ingredients
atracurium besilate
Registration type
New generic medicine
Indication
Atracurium besilate is a highly selective, competitive or non-depolarising neuromuscular blocking agent which is used as an adjunct to general anaesthesia to enable tracheal intubation to be performed and to relax skeletal muscles during surgery or controlled ventilation, and to facilitate mechanical ventilation in Intensive Care Unit (ICU) patients.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine