APX-DIENOGEST, DIENOGEST-STR, DINASANE (Arrow Pharma Pty Ltd)

Product name

APX-DIENOGEST, DIENOGEST-STR, DINASANE

Date registered

30 March 2021

Evaluation commenced

30 June 2020

Decision date

26 March 2021

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