ESTRO-PESS (Aspen Pharmacare Australia Pty Ltd)
Product name
ESTRO-PESS
Date registered
Evaluation commenced
Decision date
Approval time
186 (255 working days)
Active ingredients
estradiol (as hemihydrate)
Registration type
New generic medicine
Indication
ESTRO-PESS (modified-release pessary) is indicated for the treatment of atrophic vaginitis due to estrogen deficiency in postmenopausal women.
ESTRO-PESS is not intended for children or males.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine