SMC2296
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07/12/2020
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avatrombopag (Doptelet)
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Full
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For the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.
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|
SMC2307
|
07/12/2020
|
mexiletine (Namuscla)
|
Resubmission
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Symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.
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|
SMC2293
|
07/12/2020
|
venetoclax (Venclyxto)
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Full
|
In combination with obinutuzumab (VenG) is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
|
|
SMC2292
|
07/12/2020
|
bempedoic acid (Nilemdo)
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Full
|
In adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia, as an adjunct to diet:
- in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contra-indicated
|
|
SMC2264
|
09/11/2020
|
patiromer (Veltassa)
|
Resubmission
|
For the treatment of hyperkalaemia in adults.
|
|
SMC2298
|
09/11/2020
|
trastuzumab emtansine (Kadcyla)
|
Full
|
As a single agent, for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and / or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.
|
|
SMC2267
|
09/11/2020
|
atezolizumab (Tecentriq)
|
Full
|
In combination with nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
|
|
SMC2297
|
09/11/2020
|
darolutamide (Nubeqa)
|
Full
|
For the treatment of adult men with non-metastatic castration resistant prostate cancer who are at high risk of developing metastatic disease.
|
|
SMC2279
|
09/11/2020
|
atezolizumab (Tecentriq)
|
Full
|
In combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer.
|
|
SMC2299
|
09/11/2020
|
volanesorsen sodium (Waylivra)
|
Ultra-orphan initial assessment
|
As an adjunct to diet in adult patients with genetically confirmed familial chylomicronaemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
|
|
SMC2283
|
09/11/2020
|
trabectedin (Yondelis)
|
Resubmission
|
Treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
|
|
SMC2280
|
09/11/2020
|
romosozumab (Evenity)
|
Full
|
Treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
|
|
SMC2248
|
12/10/2020
|
avelumab (Bavencio)
|
Full
|
In combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
|
|
SMC2265
|
12/10/2020
|
siponimod (Mayzent)
|
Full
|
For the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.
|
|
SMC2281
|
12/10/2020
|
lenalidomide (Revlimid)
|
Full
|
In combination with rituximab (anti-CD20 antibody) for the treatment of adult patients with previously treated Follicular Lymphoma (Grade 1 - 3a).
|
|
SMC2290
|
12/10/2020
|
carfilzomib (Kyprolis)
|
Resubmission
|
In combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
|
|
SMC2278
|
12/10/2020
|
meropenem/vaborbactam (Vaborem)
|
Full
|
For the treatment of the following infections in adults:
- Complicated urinary tract infection (cUTI), including pyelonephritis
- Complicated intra-abdominal infection (cIAI)
- Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
The treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
|
|
SMC2289
|
12/10/2020
|
lenalidomide (Revlimid)
|
Full
|
As monotherapy is indicated in multiple myeloma (MM) for the maintenance treatment of adult patients with newly diagnosed MM who have undergone autologous stem cell transplantation (ASCT).
|
|
SMC2259
|
12/10/2020
|
ibrutinib (Imbruvica)
|
Full
|
In combination with rituximab for the treatment of adult patients with Waldenström's macroglobulinaemia.
|
|
SMC2286
|
12/10/2020
|
cerliponase alfa (Brineura)
|
Ultra-orphan initial assessment
|
For the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.
|
|