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SMC ID Date Medicine Submission Type Indication
1251/17 08/02/2021 afamelanotide (Scenesse) Full

for prevention of photoxicity in adult patients with erythropoietic protoporphyria (EPP). Scenesse is to be administered under a Post-Authorisation Safety Study (PASS) protocol in line with the approved European Medicines Agency Risk Management Plan.

SMC2280 09/11/2020 romosozumab (Evenity) Full

Treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

1236/17 12/08/2019 empaglifozin linagliptin fixed-dose combination (Glyxambi) Abbreviated

Indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control when already being treated with the free combination of empagliflozin and linagliptin

SMC2180 08/07/2019 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.

1327/18 11/06/2018 telotristat (Xermelo) Full

for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin anologue (SSA) therapy in adults inadequately controlled by SSA therapy.

1316/18 07/05/2018 regorafenib (Stivarga) Full 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) Full indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC)
1139/16 09/04/2018 teduglutide (Revestive) Full Treatment of patients aged 1 year and above with short bowel syndrome.
1317/18 09/04/2018 sofosbuvir/velpatasvir/voxilprevir (Vosevi) Full Indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults
1314/18 09/04/2018 sarilumab (Kevzara) Full 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) Full Treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal 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.
1296/18 12/03/2018 pembrolizumab (Keytruda) Full monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin.
1297/18 12/03/2018 atezolizumab (Tecentriq) Full As monotherapy, indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma after prior platinum - containing chemotherapy or who are considered cisplatin ineligible.
158/05 13/11/2017 pegvisomant (Somavert) Resubmission Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize insulin-like growth factor type 1 (IGF-1) concentrations or was not tolerated
1271/17 09/10/2017 sofosbuvir/velpatasvir (Epclusa) Full Treatment of chronic hepatitis C virus (HCV) infection in adults
1281/17 09/10/2017 opicapone (Ongentys) Non submission Adjunctive therapy to preparations of levodopa / DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
1282/17 09/10/2017 maraviroc (Celsentri) Non submission In combination with other antiretroviral medicinal products for treatment-experienced adolescents and children of 2 years and older and weighing at least 10kg infected with only CCR5-tropic HIV-1 detectable.
1205/17 09/10/2017 daratumumab (Darzalex) Resubmission As monotherapy, for the treatment of adult patients with relapsed and refectory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and have demonstrated disease progression on the last therapy.
1274/17 09/10/2017 beclometasone dipropionate anhydrous/formoterol fumarate dihydrate/glycopyrronium bromide (Trimbow) Abbreviated

Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.

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Publication due date SMC meeting date Medicine Submission Type Indication
TBC TBC durvalumab (Imfinzi) Full

IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).

TBC TBC zilucoplan (Zilbrysq) Full

As an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti‑acetylcholine receptor (AChR) antibody positive.

TBC TBC vorasidenib (Voranigo) Full

For the treatment of grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation in adults and paediatric patients 12 years and older, who are not in need of immediate chemotherapy or radiotherapy following surgical intervention.

progesterone (Lubion)-Abbreviated-SMC2017
fluticasone/formoterol (flutiform k-haler)-Abbreviated-SMC2016
obinutuzumab (Gazyvaro)-Resubmission-SMC2015
tocilizumab (RoActemra)-Fullsubmission-SMC2014
dupilumab (Dupixent)-Fullsubmission-SMC2011
sapropterin (Kuvan)-Fullsubmission-SMC558/09
sofosbuvir 400mg film-coated tablets (Sovaldi)-Non Submission-1326/18
nilotinib-Tasigna-Non-Submission-1325/18
lacosamide-Vimpat-Non-Submission-1324/18
elvitegravir 150mg / cobicistat 150 mg / emtricitabine 200 mg / tenofovir alafenamide 10 mg (Genvoya)-Non Submission-1323/18
dexamethasone 40mg tablets (Neofordex)-Non Submission-1322/18
clostridium botulinum type A toxin-haemagglutinin complex 300 and 500 units (Dysport)-nonsubmission-1321/18
tofacitinib (Xeljanz)-Fullsubmission-1298/18
tivozanib (Fotivda)-Fullsubmission-SMC1335/18
tiotropium (Spiriva Respimat)-AbbreviatedSubmission-411/07
sofosbuvir / velpatasvir (Epclusa)-Resubmission-1271/17
sevelamer carbonate (Renvela)-AbbreviatedSubmission-1304/18
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