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SMC ID Date Medicine Submission Type Indication
SMC2930 07/09/2026 capivasertib (Truqap) Resubmission

In combination with fulvestrant for the treatment of adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-; defined as IHC 0 or 1+, or IHC 2+/ISH) locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine based regimen.
SMC2933 07/09/2026 elacestrant (Korserdu) Resubmission

For the treatment of postmenopausal women, and men, with oestrogen receptor-positive (ER+), human epidermal factor receptor 2-negative (HER2-), locally advanced or metastatic (m) breast cancer (BC) with an activating oestrogen receptor 1 (ESR1) mutation (mut) who have disease progression following at least one line of endocrine therapy (ET) including a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i).
SMC2199 11/11/2019 lenvatinib (Kisplyx) Full

In combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
1331/18 11/06/2018 everolimus (Votubia) Full Adjunctive treatment of patients aged 2 years and older whose refractory partial -onset seizures, with or without secondary generalisation, are associated with tuberous sclerosis complex.
1288/17 13/11/2017 everolimus (Certican) Non submission Prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogenic renal transplant.
1215/17 13/02/2017 everolimus (Afinitor) Full for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.
872/13 11/04/2016 everolimus (Afinitor) Resubmission Treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2/neu-negative [HER2–]) advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor (NSAI).
1117/15 09/11/2015 everolimus (Certican) Non submission Prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a cardiac transplant; Prophylaxis of organ rejection in patients receiving a hepatic transplant.
595/10 10/11/2014 everolimus (Afintor) Resubmission The treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.
884/13 10/06/2013 everolimus (Votubia) Non submission Treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.
777/12 14/05/2012 everolimus (Afinitor) Full Treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin (pNET) in adults with progressive disease.
787/12 09/04/2012 everolimus (Votubia) Non submission Treatment of patients aged 3 years and older with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.

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