13/06/2022
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|
lenvatinib (Kisplyx)
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Abbreviated
|
In combination with pembrolizumab for the first‑line treatment of advanced renal cell carcinoma in adults
|
|
13/06/2022
|
03/05/2022
|
tepotinib (Tepmetko)
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Full
|
For treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.
|
|
13/06/2022
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03/05/2022
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ixekizumab (Taltz)
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Full
|
For treatment of adult patients with active radiographic axial spondyloarthritis (rad-axSpA; also known as ankylosing spondylitis [AS] in the literature) who have responded inadequately to conventional therapy and adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
|
|
13/06/2022
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TBC
|
abrocitinib (Cibinqo)
|
Full
|
Treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
|
|
13/06/2022
|
|
relugolix/estradiol/norethisterone acetate (Ryeqo)
|
Full
|
For treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
|
|
11/07/2022
|
07/06/2022
|
crizanlizumab (Adakveo)
|
Full
|
Prevention of recurrent vaso-occlusive crises (VOC) in sickle cell disease (SCD) patients aged 16 years and older, as either an add-on therapy to hydroxyurea/hydroxycarbamide (HC/HU) or as monotherapy in patients for whom HC/HU is inappropriate or inadequate.
|
|
11/07/2022
|
07/06/2022
|
solriamfetol (Sunosi)
|
Full
|
To improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with narcolepsy (with or without cataplexy).
|
|
11/07/2022
|
01/03/2022
|
odevixibat (Bylvay)
|
Ultra-orphan initial assessment
|
For treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older
|
|
TBC
|
02/10/2018
|
padeliporfin (TOOKAD)
|
Full
|
Indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and:
- Clinical stage T1c or T2a,
- Gleason Score ≤ 6, based on high-resolution biopsy strategies,
- PSA ≤ 10 ng/mL,
- 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm3.
|
|
TBC
|
TBC
|
buprenorphine and naloxone (Zubsolv)
|
Abbreviated
|
Substitution treatment for opioid drug dependence.
|
|
TBC
|
|
beclometasone dipropionate/formoterol fumarate dehydrate/glycopyrronium bromide (Trimbow)
|
Abbreviated
|
Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.
|
|
TBC
|
TBC
|
tofacitinib (Xeljanz)
|
Abbreviated
|
Treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive or negative polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs. Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
|
|
TBC
|
|
trifarotene (Aklief)
|
Abbreviated
|
Cutaneous treatment of Acne Vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and pustules are present.
|
|
TBC
|
TBC
|
daratumumab (Darzalex)
|
Full
|
In combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis.
|
|
TBC
|
TBC
|
imlifidase (Idefirix)
|
Full
|
Desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of imlifidase should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.
|
|
TBC
|
TBC
|
pegcetacoplan (Aspaveli)
|
Full
|
Treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months.
|
|
TBC
|
TBC
|
zanubrutinib (Brukinsa)
|
Full
|
For the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
|
|
TBC
|
TBC
|
delafloxacin (Quofenix)
|
Full
|
Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections.
|
|
TBC
|
TBC
|
belimumab (Benlysta)
|
Full
|
Add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy.
|
|
TBC
|
TBC
|
upadacitinib (Rinvoq)
|
Full
|
Treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
|
|