SMC2340
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08/02/2021
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apremilast (Otezla)
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Non submission
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Treatment of adult patients with oral ulcers associated with Behçet’s disease who are candidates for systemic therapy.
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SMC2341
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08/02/2021
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glasdegib (Daurismo)
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Non submission
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In combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.
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SMC2339
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08/02/2021
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alpelisib (Piqray)
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Non submission
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In combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.
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SMC2344
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08/02/2021
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omalizumab (Xolair)
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Non submission
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As add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe chronic rhinosinusitis with nasal polyps for whom therapy with INC does not provide adequate disease control.
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SMC2343
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08/02/2021
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mercaptamine (Cystadrops)
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Non submission
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Treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.
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SMC2316
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08/02/2021
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buprenorphine/naloxone (Suboxone)
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Abbreviated
|
Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Suboxone is indicated in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
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SMC2320
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08/02/2021
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leuprorelin acetate (Prostap DCS)
|
Abbreviated
|
As treatment in pre- and perimenopausal women with advanced breast cancer suitable for hormonal manipulation.
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SMC2319
|
08/02/2021
|
leuprorelin acetate (Prostap DCS)
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Abbreviated
|
As adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in pre- and perimenopausal women at higher risk of disease recurrence (young age, high grade tumour, lymph node involvement). In women who have received chemotherapy, premenopausal status must be confirmed after completion of chemotherapy.
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SMC2309
|
08/02/2021
|
ozanimod (Zeposia)
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Full
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For adult patients with relapsing remitting multiple sclerosis.
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SMC2305
|
08/02/2021
|
ravulizumab (Ultomiris)
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Full
|
For the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH): • in patients with haemolysis with clinical symptom(s) indicative of high disease activity • in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months.
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SMC2315
|
08/02/2021
|
upadacitinib (Rinvoq)
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Full
|
For treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate.
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1251/17
|
08/02/2021
|
afamelanotide (Scenesse)
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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.
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SMC2342
|
08/02/2021
|
imipenem/cilastatin/relabactam (Recarbrio)
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Non submission
|
Indication under review: For the treatment of:
- hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults
- bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults.
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SMC2321
|
08/02/2021
|
formoterol fumarate dihydrate/glycopyrronium/budesonide (Trixeo Aerosphere)
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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 or combination of a long-acting beta2‑agonist and a long‑acting muscarinic antagonist.
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SMC2323
|
18/01/2021
|
apalutamide (Erleada)
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Non submission
|
In adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
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SMC2325
|
18/01/2021
|
talazoparib (Talzenna)
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Non submission
|
As monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer.
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SMC2324
|
18/01/2021
|
dupilumab (Dupixent)
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Non submission
|
As an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
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|
SMC2308
|
18/01/2021
|
secukinumab (Cosentyx)
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Full
|
For the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
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|
SMC2326
|
18/01/2021
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daratumumab (Darzalex)
|
Abbreviated
|
In combination with bortezomib, thalidomide and dexamethasone is indicated for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
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|
SMC2306
|
18/01/2021
|
melatonin (Slenyto)
|
Resubmission
|
For the treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.
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