The Expert Committee recommended inclusion of letrozole on the complementary list of the EML for the treatment of anovulatory infertility associated with polycystic ovary syndrome or unexplained infertility. Listing was recommended with anastrozole as a therapeutic alternative under a square box listing. The Committee noted evidence that letrozole is associated with a moderate increase in live births and clinical pregnancies compared to clomifene (a medicine currently included in the EML) in patients with infertility due to polycystic ovary syndrome, and similar efficacy to clomifene for live births or biochemically tested pregnancy in couples with unexplained infertility. The Committee noted that WHO guidelines for the prevention, diagnosis and treatment of infertility are in development, and are expected to include recommendations for use of letrozole for ovulation induction in these populations.