ARZESTRA (Anthia Life Sciences Pty Ltd)
Product name
ARZESTRA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
137 (255 working days)
Active ingredients
mifepristone, misoprostol
Registration type
New generic medicine
Indication
ARZESTRA is indicated in females of childbearing age for the medical termination of an intrauterine pregnancy, up to 63 days of gestation.
It is recommended that the duration of pregnancy (i.e., up to 63 days gestation) be confirmed by ultrasound. In the event that an ultrasound is not possible, extra caution should be exercised.
Ultrasound is also useful to exclude ectopic pregnancy.