OVALEAP (Theramex Australia Pty Ltd)
Product name
OVALEAP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
187 (255 working days)
Active ingredients
follitropin alfa
Registration type
NCE/NBE
Indication
OVALEAP (solution for injection) is indicated for:
- The treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated.
- For controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies.
- OVALEAP is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.