SMC2654
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12/08/2024
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trifluridine tipiracil (Lonsurf)
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Full
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In combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (CRC) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.
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SMC2649
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12/08/2024
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etranacogene dezaparvovec (Hemgenix)
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Full
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For treatment of severe and moderately severe haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors.
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SMC2706
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12/08/2024
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trastuzumab deruxtecan (Enhertu)
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Non submission
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As monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
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SMC2705
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12/08/2024
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talquetamab (Talvey)
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Non submission
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As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
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SMC2702
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12/08/2024
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fezolinetant (Veoza)
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Non submission
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Treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
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SMC2704
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12/08/2024
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nivolumab (Opdivo)
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Non submission
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Adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma.
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SMC2713
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24/07/2024
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ivacaftor-tezacaftor-elexacaftor (Kaftrio)
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Collaboration
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in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in patients aged 2 years to less than 6 years (granules in sachet) and 6 years and older (film-coated tablets) who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
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SMC2712
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24/07/2024
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lumacaftor-ivacaftor (Orkambi)
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Collaboration
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treatment of cystic fibrosis (CF) in patients aged 1 year and older (granules in sachet) or 6 years and older (film-coated tablets) who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
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SMC2711
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24/07/2024
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tezacaftor-ivacaftor (Symkevi)
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Collaboration
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in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (CF) aged 6 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.
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SMC2641
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08/07/2024
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voretigene neparvovec (Luxturna)
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Ultra-orphan reassessment
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For the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.
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SMC2642
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08/07/2024
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empagliflozin (Jardiance)
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Full
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In adults for the treatment of chronic kidney disease.
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SMC2644
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08/07/2024
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pembrolizumab (Keytruda)
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Full
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In combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.
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SMC2645
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08/07/2024
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nivolumab / relatlimab (Opdualag)
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Full
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For treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and over.
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SMC2651
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08/07/2024
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birch bark extract (Filsuvez)
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Ultra-orphan initial assessment
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For treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients aged 6 months and older.
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SMC2660
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08/07/2024
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pembrolizumab (Keytruda)
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Full
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in combination with fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.
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SMC2665
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08/07/2024
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pegunigalsidase alfa (Elfabrio)
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Resubmission
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Long-term enzyme replacement therapy (ERT) in adult patients with confirmed diagnosis of Fabry disease (FD) (deficiency of alpha galactosidase).
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SMC2670
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08/07/2024
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follitropin delta (Rekovelle)
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Abbreviated
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Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
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SMC2691
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08/07/2024
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lenacapavir (Sunlenca)
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Non submission
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Film-coated tablets: in combination with other antiretroviral(s) for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen, for oral loading prior to administration of long-acting lenacapavir injection.
Solution for injection: in combination with other antiretroviral(s) for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
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SMC2692
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08/07/2024
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remimazolam (Byfavo)
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Non submission
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In adults for intravenous induction and maintenance of general anaesthesia.
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SMC2693
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08/07/2024
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trastuzumab deruxtecan (Enhertu)
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Non submission
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As monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
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