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CETRORELIX RBX (Sun Pharma ANZ Pty Ltd)
Product name
CETRORELIX RBX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
137 (255 working days)
Active ingredients
cetrorelix
Registration type
New generic medicine
Indication
Prevention of premature luteinisation and ovulation in patients undergoing a controlled ovarian stimulation followed by oocyte pick up and assisted reproductive techniques.
In clinical trials cetrorelix was used with human menopausal gonadotrophin (HMG), however limited experience with recombinant FSH suggested similar efficacy.