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SMC ID Date Medicine Submission Type Indication
SMC2137 13/05/2019 cariprazine (Reagila) Full for the treatment of schizophrenia in adult patients.
SMC2159 13/05/2019 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.
SMC2144 13/05/2019 pembrolizumab (Keytruda) Full as monotherapy for the adjuvant treatment of adults with stage III melanoma and lymph node involvement who have undergone complete resection
SMC2193 13/05/2019 rituximab (MabThera) Non submission Treatment of patients with moderate to severe pemphigus vulgaris.
SMC2191 13/05/2019 daratumumab (Darzalex) Non submission In combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
SMC2192 13/05/2019 dasatinib (Sprycel) Non submission The treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia in combination with chemotherapy.
SMC2140 13/05/2019 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
SMC2190 13/05/2019 chenodeoxycholic acid (Chenodeoxycholic acid Leadiant) Non submission The treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia in combination with chemotherapy.
SMC2135 13/05/2019 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
SMC2179 13/05/2019 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
SMC2152 08/04/2019 testosterone (Testavan) Abbreviated For replacement therapy for adult male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
SMC2139 08/04/2019 mepolizumab (Nucala) Abbreviated Add-on therapy for children (6y+), adolescents, and adults with severe refractory eosinophilic asthma
SMC2148 08/04/2019 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
SMC2142 08/04/2019 dasatinib (Sprycel) Abbreviated the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib
SMC2134 08/04/2019 erenumab (Aimovig) Full for the prophylaxis of migraine in adults who have at least 4 migraine days per month
SMC2132 08/04/2019 certolizumab pegol (Cimzia) Full Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy
SMC2138 08/04/2019 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
SMC2146 08/04/2019 rufinamide (Inovelon) Abbreviated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 1 years of age and older
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).
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).
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Publication due date SMC meeting date Medicine Submission Type Indication
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 patisiran (Onpattro) Full For the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
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 02/04/2019 fingolimod (Gilenya) Abbreviated As single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1 of the SmPC), Or: Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
10/06/2019 07/05/2019 nivolumab (Opdivo) Full In combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma.
08/07/2019 04/06/2019 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
08/07/2019 04/06/2019 palbociclib (Ibrance) Full for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer -in combination with fulvestrant in women who have received prior endocrine therapy
08/07/2019 04/06/2019 arsenic trioxide (Trisenox) Resubmission For induction of remission and consolidation in adult patients with: • Newly diagnosed, low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤10 x 103/µl) in combination with all-trans-retinoic acid (ATRA) • Relapsed/refractory APL (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene.
08/07/2019 04/06/2019 daratumumab (Darzalex) Full In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
08/07/2019 04/12/2018 darvadstrocel (Alofisel) Full Treatment of complex perianal fistula(s) in adult patients with non-active/mildly active luminal Crohn’s disease (CD), when fistula(s) have shown an inadequate response to at least one conventional or biologic therapy.
12/08/2019 02/07/2019 inotersen (Tegsedi) Full For the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).
12/08/2019 02/07/2019 venetoclax (Venclyxto) Full In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
12/08/2019 02/07/2019 tildrakizumab (Ilumetri) Full Treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
12/08/2019 02/07/2019 buprenorphine (Buvidal) Full For the treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.
12/08/2019 02/07/2019 perampanel (Fycompa) Abbreviated Adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.
09/09/2019 06/08/2019 dolutegravir lamivudine (Dovato) Abbreviated Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.
09/09/2019 06/08/2019 zanamivir (Dectova) Abbreviated Treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥ 6 months) when: • The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or • Other anti-viral agents for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.
09/09/2019 06/08/2019 ospemifene (Senshio) Full For the treatment of moderate to severe symptomatic vulvar and vaginal atrophy in post-menopausal women who are not candidates for local vaginal oestrogen therapy.
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