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SMC ID Date Medicine Indication
1318/18 07/05/2018 nusinersen (Spinraza) Treatment of 5q spinal muscular atrophy.
1332/18 07/05/2018 icatibant (Firazyr) Symptomatic treatment of acute attacks of hereditary angioedema in adolescents and children aged 2 years and older (with C1-esterase-inhibitor deficiency).
1283/17 07/05/2018 brodalumab (Kyntheum) For the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy.
1316/18 07/05/2018 regorafenib (Stivarga) As a monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously tretated with sorafenib
1315/18 07/05/2018 avelumab (Bavencio) indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC)
SMC2085 07/05/2018 brentuximab vedotin (Adcetris)
SMC2086 07/05/2018 naltrexone bupropion (Mysimba)
1235/17 07/05/2018 selexipag (Uptravi) For the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II-III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.
1271/17 09/04/2018 sofosbuvir / velpatasvir (Epclusa) The licensed indication for SOF/VEL covers chronic HCV infection of any genotype (GT1-6) in patients without cirrhosis, those with compensated cirrhosis and those with decompensated cirrhosis. The current submission covers genotypes 1 and 4 patients without or with compensated cirrhosis. SOF/VEL has received prior approval from the SMC for the treatment of CHC GT2, 3, 5 and 6 patients without or with compensated cirrhosis as well as patients with decompensated cirrhosis irrespective of CHC genotype (2, 3).
1320/18 09/04/2018 ciprofloxacin hydrochloride (Cetraxal) Treatment of acute otitis externa in adults and children older than 1 year with an intact tympanic membrane, caused by ciprofloxacin susceptible microorganisms.
1319/18 09/04/2018 asparaginase (Spectrila) Component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia in paediatric patients from birth to 18 years and adult patients.
1139/16 09/04/2018 teduglutide (Revestive) Treatment of patients aged 1 year and above with short bowel syndrome.
1317/18 09/04/2018 sofosbuvir/velpatasvir/voxilprevir (Vosevi) Indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults
1314/18 09/04/2018 sarilumab (Kevzara) In combination with methotrexate, or as monontherapy, for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs. Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.
1313/18 09/04/2018 dimethyl fumarate (Skilarence) Treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
1333/18 09/04/2018 ceritinib (Zykadia) As monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer.
1334/18 09/04/2018 parathyroid hormone (Natpar) As adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.
1326/18 12/03/2018 sofosbuvir 400mg film-coated tablets (Sovaldi) In combination with other medicinal products for the treatment of chronic hepatitis C in adolescents aged 12 to <18 years.
1325/18 12/03/2018 nilotinib 150mg and 200mg hard capsules (Tasigna) • paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase • paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib
1324/18 12/03/2018 lacosamide 50mg, 100mg, 150mg, 200mg tablets 10mg/mL syrup and 10mg/mL solution for intravenous infusion (Vimpat) As monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adolescents and children from 4 years of age with epilepsy
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Advice due date SMC meeting date Medicine Indication
11/06/2018 01/05/2018 fluticasone/formoterol (flutiform k-haler) 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: • For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting β2 agonist. • For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist. • flutiform k-haler) is indicated in adults and adolescents aged 12 years and above.
11/06/2018 01/05/2018 midostaurin (Rydapt) for AML Treatment of adult patients with newly diagnosed acute myeloid leukaemia who are FLT3 mutation positive in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintenance therapy.
11/06/2018 01/05/2018 ledispavir / sofosbuvir (Harvoni) Treatment of chronic hepatitis C infection in adolescents aged 12 to < 18 years
11/06/2018 01/05/2018 guselkumab (Tremfya) Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy
11/06/2018 01/05/2018 everolimus (Votubia) 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.
11/06/2018 01/05/2018 crizotinib (Xalkori) Treatment of adults with ROS1-positive advanced non-small cell lung cancer.
09/07/2018 05/06/2018 progesterone (Lubion) Indicated in adults for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women who are unable to use or tolerate vaginal preparations.
09/07/2018 05/06/2018 tivozanib (Fotivda) For the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mammalian target of rapamycin (mTOR) pathway inhibitor-naive following disease progression after one prior treatment with cytokine therapy for advanced RCC.
09/07/2018 05/06/2018 ocrelizumab (Ocrevus) Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features
09/07/2018 05/06/2018 lutetium 177Lu oxodotreotide (Lutathera) Unresectable or metastatic, progressive, well differentiated (G1 and G2) somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours in adults.
09/07/2018 05/06/2018 letermovir (Prevymis) Prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant
09/07/2018 05/06/2018 atezolizumab (Tecentriq) for NSCLC Treatment of adult patients with locally advanced ot metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Patients with EGFR activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving Tecentriq.
13/08/2018 03/07/2018 sapropterin (Kuvan) Treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment.
13/08/2018 03/07/2018 niraparib tosylate monohydrate (Zejula) As monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy
13/08/2018 03/07/2018 conestat alfa (Ruconest) Treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency
13/08/2018 03/07/2018 obinutuzumab (Gazyvaro) In combination with chemotherapy, followed by maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma (FL).
13/08/2018 03/07/2018 patiromer sorbitex calcium (Veltassa) For the treatment of hyperkalaemia in adults in patients with advanced CKD (stage 3-4) on RAAS inhibitor treatment who develop hyperkalaemia.
13/08/2018 03/07/2018 dupilumab (Dupixent) For treatment of moderate-to-severe atopic dermatitis.
10/09/2018 07/08/2018 eslicarbazepine acetate (Zebinix) For adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures with or without secondary generalisation.
10/09/2018 07/08/2018 dolutegravir rilpivirine (Juluca) For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA copies <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase strand transfer inhibitor (INSTI).
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