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GANIRELIX SUN (Sun Pharma ANZ Pty Ltd)
Product name
GANIRELIX SUN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
146 working days (255)
Active ingredients
ganirelix acetate
Registration type
New generic medicine
Indication
GANIRELIX SUN (solution for injection) is indicated for the prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick up and assisted reproductive techniques.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine