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SMC ID Date Medicine Submission Type Indication
SMC2803 10/11/2025 ribociclib (Kisqali) Full

In combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence.s

In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

SMC2198 11/11/2019 ribociclib (Kisqali) Full

For the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.

1295/18 12/03/2018 ribociclib (Kisqali) Full for use in combination with an aromatase inhibitor (AI), for the treatment of postmenopausal women with HR+/human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.

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