26/10/2023
|
TBC
|
budesonide/formoterol (Symbicort)
|
Full
|
Symbicort Turbohaler 200/6 as reliever therapy for adults and adolescents ≥12 years with mild asthma
|
|
11/12/2023
|
|
degarelix (Firmagon)
|
Abbreviated
|
- for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy
- as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer
|
|
11/12/2023
|
|
bimekizumab (Bimzelx)
|
Abbreviated
|
Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs) and adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
|
|
11/12/2023
|
|
cipaglucosidase alfa (Pombiliti)
|
Abbreviated
|
Long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset Pompe disease (LOPD; acid α-glucosidase [GAA] deficiency.
|
|
11/12/2023
|
07/11/2023
|
cemiplimab (Libtayo)
|
Reassessment
|
As monotherapy for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.
|
|
11/12/2023
|
07/11/2023
|
trastuzumab deruxtecan (Enhertu)
|
Full
|
As monotherapy for the treatment of adult patients with unresectable or metastatic HER2‑low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
|
|
11/12/2023
|
|
deucravacitinib (Sotyktu)
|
Full
|
Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
|
|
11/12/2023
|
|
nivolumab (Opdivo)
|
Full
|
In combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable (tumours ≥ 4 cm or node positive) non-small cell lung cancer in adults.
|
|
15/01/2024
|
05/12/2023
|
burosumab (Crysvita)
|
Ultra-orphan reassessment
|
Treatment of X-linked hypophosphataemia in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease.
|
|
15/01/2024
|
05/12/2023
|
belantamab mafodotin (Blenrep)
|
Full
|
Monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
|
|
12/02/2024
|
09/01/2024
|
loncastuximab tesirine (Zynlonta)
|
Full
|
As monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.
|
|
12/02/2024
|
09/01/2024
|
dupilumab (Dupixent)
|
Full
|
Treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
|
|
12/02/2024
|
09/01/2024
|
cabozantinib (Cabometyx)
|
Full
|
As monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.
|
|
TBC
|
07/02/2023
|
tebentafusp (Kimmtrak)
|
Full
|
as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma
|
|
TBC
|
10/01/2023
|
levodopa/carbidopa/entacapone (Lecigon)
|
Full
|
For treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson medicinal products have not given satisfactory results
|
|
TBC
|
TBC
|
secukinumab (Cosentyx)
|
Full
|
Treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy.
|
|
TBC
|
|
foslevodopa-foscarbidopa (Produodopa)
|
Abbreviated
|
Treatment of advanced levodopa-responsive Parkinson’s disease (PD) with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.
|
|
TBC
|
TBC
|
talazoparib (Talzenna)
|
Full
|
As monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
|
|
TBC
|
TBC
|
ritlecitinib (Litfulo)
|
Full
|
Treatment of severe alopecia areata in adults and adolescents aged 12 years and over.
|
|
TBC
|
TBC
|
daridorexant (Quviviq)
|
Full
|
Treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.
|
|