BELLA ETHINYLOESTRADIOL/DROPIRENONE, ETHINYLOESTRADIOL/DROPIRENONE GENERIC HEALTH, ETHINYLOESTRADIOL/DROPIRENONE GH, ETHINYLOESTRADIOL/DROPIRENONE LAPL, ETHINYLOESTRADIOL/DROPIRENONE LL, ETHINYLOESTRADIOL/DROPIRENONE LUPIN (Lupin Australia Pty Limited)
Product name
BELLA ETHINYLOESTRADIOL/DROPIRENONE, ETHINYLOESTRADIOL/DROPIRENONE GENERIC HEALTH, ETHINYLOESTRADIOL/DROPIRENONE GH, ETHINYLOESTRADIOL/DROPIRENONE LAPL, ETHINYLOESTRADIOL/DROPIRENONE LL, ETHINYLOESTRADIOL/DROPIRENONE LUPIN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
230 working days (255)
Active ingredients
ethinyloestradiol, drospirenone
Registration type
New generic medicine
Indication
BELLA ETHINYLOESTRADIOL/DROPIRENONE, ETHINYLOESTRADIOL/DROPIRENONE GENERIC HEALTH, ETHINYLOESTRADIOL/DROPIRENONE GH, ETHINYLOESTRADIOL/DROPIRENONE LAPL, ETHINYLOESTRADIOL/DROPIRENONE LL, ETHINYLOESTRADIOL/DROPIRENONE LUPIN (film coated tablet) is indicated for use as:
- an oral contraceptive.
- treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of ethinylestradiol/drospirenone tablet for PMDD was not assessed beyond 3 cycles. Ethinylestradiol/ drospirenone tablet has not been evaluated for treatment of PMS (premenstrual syndrome).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine