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APX-DIENOGEST, DIENOGEST-STR, DINASANE (Arrow Pharma Pty Ltd)
Product name
APX-DIENOGEST, DIENOGEST-STR, DINASANE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
148 (255 working days)
Active ingredients
dienogest
Registration type
New generic medicine
Indication
APX-DIENOGEST, DIENOGEST-STR, DINASANE (tablet) is indicated for the treatment of endometriosis.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine