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GANIRELIX THERAMEX (Theramex Australia Pty Ltd)
Product name
GANIRELIX THERAMEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
97 (255 working days)
Active ingredients
Ganirelix
Registration type
New generic medicine
Indication
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