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SMC ID Date Medicine Submission Type Indication
1338/18 11/03/2019 letermovir (Prevymis) Full Prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant
SMC2130 11/03/2019 liposomal formulation of daunorubicin & cytarabine (Vyxeos) Full Treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AMC-MRC)
SMC2141 11/03/2019 tisagenlecleucel (Kymriah) Full for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B‑cell lymphoma (DLBCL) after two or more lines of systemic therapy
SMC2165 11/03/2019 rituxumab (MabThera) Non submission In combination with glucocorticoids, for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).
SMC2164 11/03/2019 epoetin alfa (Eprex) Non submission Treatment of symptomatic anaemia (haemoglobin concentration of ≤10g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/mL).
SMC2087 11/02/2019 eslicarbazepine acetate (Zebinix) Abbreviated For adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures with or without secondary generalisation.
SMC2114 11/02/2019 axicabtagene ciloleucel (Yescarta) Full for treating relapsed or refractory diffuse large B-cell non-Hodgkin lymphoma
SMC2127 11/02/2019 pembrolizumab (Keytruda) Full In combination with pemetrexed and platinum chemotherapy for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations
SMC2129 11/02/2019 tisagenlecleucel (Kymriah) Full Treatment of paediatric and young adult patients up to 25 years with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse
SMC2122 11/02/2019 tofacitinib (Xeljanz) Full For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to conventional therapy or a biologic agent
SMC2126 11/02/2019 romiplostim (Nplate) Abbreviated Chronic immune (idiopathic) thrombocytopenic purpura patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins)
SMC2128 11/02/2019 rivaroxaban (Xarelto) Full Co-administered with acetylsalicylic acid (ASA) for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events
SMC2131 11/02/2019 dabrafenib (Tafinlar) Full In combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection
SMC2136 11/02/2019 cabozantinib (Cabometyx) Resubmission treatment of advanced renal cell carcinoma (RCC) in treatment-naïve adults with intermediate or poor risk per IMDC criteria
SMC2160 11/02/2019 cabozantinib (Cabometyx) Non submission As monotherapy for the treatment of hepatocellular carcinoma in adults who have previously been treated with sorafenib.
SMC2161 11/02/2019 dexmedetomidine (Dexdor) Non submission Sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.
SMC2162 11/02/2019 doravirine (Pifeltro) Non submission In combination with other antiretroviral medicinal products, for the treatment of adults infected with human immunodeficiency virus 1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor class.
SMC2163 11/02/2019 doravirine/lamivudine/tenofovir disoproxil (Delstrigo) Non submission Treatment of adults infected with human immunodeficiency virus 1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor class, lamivudine, or tenofovir.
SMC2102 14/01/2019 ertugliflozin (Steglatro) Full In adults aged 18 years and older with T2DM as an adjunct to diet and exercise to improve glycaemic control: • As monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. • In addition to other medicinal products for the treatment of diabetes.
SMC2116 14/01/2019 tofacitinib (Xeljanz) Full In combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy.
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Advice due date SMC meeting date Medicine Submission Type Indication
08/04/2019 05/03/2019 erenumab (Aimovig) Full for the prophylaxis of migraine in adults who have at least 4 migraine days per month
08/04/2019 05/03/2019 mepolizumab (Nucala) Abbreviated Add-on therapy for children (6y+), adolescents, and adults with severe refractory eosinophilic asthma
08/04/2019 05/03/2019 testosterone (Testavan) Abbreviated For replacement therapy for adult male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
08/04/2019 05/03/2019 certolizumab pegol (Cimzia) Full Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy
08/04/2019 05/03/2019 blinatumomab (Blincyto) Abbreviated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation
08/04/2019 05/03/2019 rufinamide (Inovelon) Abbreviated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 1 years of age and older
13/05/2019 02/04/2019 abemaciclib (Verzenios) Full Women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy
13/05/2019 02/04/2019 doxylamine succinate and pyridoxine hydrochloride (Xonvea) Full for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management
13/05/2019 02/04/2019 pembrolizumab (Keytruda) Full as monotherapy for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection
13/05/2019 02/04/2019 latanoprost + timolol (Fixapost) Abbreviated Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
13/05/2019 02/04/2019 abemaciclib (Verzenios) 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
13/05/2019 02/04/2019 cariprazine (Reagila) Full for the treatment of schizophrenia in adult patients
10/06/2019 07/05/2019 benralizumab (Fasenra) Full As add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.
10/06/2019 07/05/2019 fluticasone/formoterol (Flutiform) Abbreviated For the licence extension of low strength flutiform (50/5 µg) in children aged 5 to <12 years. This fixed-dose combination of fluticasone propionate and formoterol fumarate (flutiform inhaler) is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate: o For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting β2 agonist. Or o For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist. flutiform 50 microgram/5 microgram inhaler is indicated in adults, adolescents and children aged 5 years and above.
10/06/2019 07/05/2019 brigatinib (Alunbrig) Full as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib
10/06/2019 07/05/2019 durvalumab (Imfinzi) Full as monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express programmed cell death ligand 1 (PD-L1) on ≥1% of tumour cells (TCs) and whose disease has not progressed following platinum-based chemoradiation therapy (CRT)
10/06/2019 07/05/2019 patisiran (Onpattro) Full For the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
12/08/2019 02/07/2019 tildrakizumab (Ilumetri) Full Treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Q2 2019 Q2 2019 lenvatinib (Lenvima) Full as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy
Q3 2019 Q2 2019 encorafenib (Braftovi) Full encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation
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