FENTANYL MEDSURGE/ FENTANYL MEDICIANZ (Medsurge Pharma Pty Ltd)
Product name
FENTANYL MEDSURGE/ FENTANYL MEDICIANZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
147 (255 working days)
Active ingredients
fentanyl citrate
Registration type
New generic medicine
Indication
Fentanyl is indicated for:
- analgesic action of short duration during anaesthetic periods, premedication, induction ,and maintenance, and in the immediate post-operative period (recovery room) as the ,need arises;
- use as an opioid analgesic supplement in general and regional anaesthesia;
- administration with a neuroleptic such as droperidol injection as an anaesthetic ,premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of ,general and regional anaesthesia.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine