07/04/2025
|
|
eplontersen (Wainzua)
|
Abbreviated
|
For treatment of adult patients with polyneuropathy associated with hereditary transthyretin-mediated amyloidosis (ATTRv).
|
|
07/04/2025
|
|
dapagliflozin (Forxiga)
|
Abbreviated
|
In adults for the treatment of chronic kidney disease (CKD).
|
|
07/04/2025
|
TBC
|
elafibranor (Iqirvo)
|
Full
|
Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
|
|
07/04/2025
|
TBC
|
alectinib hydrochloride (Alecensa)
|
Full
|
Monotherapy as adjuvant treatment for adult patients with Stage IB (tumours ≥ 4cm) to IIIA (7th edition of the UICC/AJCC-staging system) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following complete tumour resection.
|
|
07/04/2025
|
04/03/2025
|
tebentafusp (Kimmtrak)
|
Full
|
Treatment of HLA-A*02:01-positive adult patients with advanced (unresectable or metastatic) uveal melanoma.
|
|
07/04/2025
|
|
futibatinib (Lytgobi)
|
Abbreviated
|
For treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
|
|
07/04/2025
|
04/03/2025
|
bimekizumab (Bimzelx)
|
Full
|
Treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy.
|
|
12/05/2025
|
01/04/2025
|
erdafitinib (Balversa)
|
Full
|
As monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations who have previously received at least one line of therapy containing a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-(L)1) inhibitor in the unresectable or metastatic treatment setting.
|
|
12/05/2025
|
01/04/2025
|
fruquintinib (Fruzaqla)
|
Full
|
As monotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, with or without an anti-vascular endothelial growth factor (VEGF) therapy and, if rat sarcomas virus (RAS) wildtype and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy.
|
|
12/05/2025
|
01/04/2025
|
sodium thiosulfate (Pedmarqsi)
|
Full
|
For the prevention of ototoxicity caused by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.
|
|
TBC
|
03/09/2024
|
maralixibat (Livmarli)
|
Full
|
For treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.
|
|
TBC
|
TBC
|
abaloparatide (Eladynos)
|
Full
|
Treatment of osteoporosis in postmenopausal women at increased risk of fracture.
|
|
TBC
|
TBC
|
cladribine (Mavenclad)
|
Full
|
Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease as defined by clinical or imaging features.
|
|
TBC
|
TBC
|
ruxolitinib (Jakavi)
|
Full
|
Treatment of patients aged 12 years and older with acute graft versus host disease who have inadequate response to corticosteroids.
|
|
TBC
|
TBC
|
osimertinib (Tagrisso)
|
Full
|
In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
|
|
TBC
|
TBC
|
durvalumab (Imfinzi)
|
Full
|
In combination with tremelimumab for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma.
|
|
TBC
|
TBC
|
exagamglogene autotemcel (exa-cel) (Casgevy)
|
Ultra-orphan initial assessment
|
For the treatment of transfusion-dependent β-thalassaemia in patients 12 years of age and older for whom haematopoietic stem cell transplantation is appropriate and a human leukocyte antigen (HLA)-matched related haematopoietic stem cell (HSC) donor is not available.
|
|
TBC
|
TBC
|
amivantamab (Rybrevant)
|
Full
|
In combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon20 insertion mutations.
|
|
TBC
|
TBC
|
donanemab (Kisunla)
|
Full
|
for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (APOE4) heterozygotes on non-carriers.
|
|
TBC
|
TBC
|
rucaparib (Rubraca)
|
Full
|
As monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
|
|