12/09/2022
|
02/08/2022
|
nivolumab (Opdivo)
|
Full
|
In combination with fluoropyrimidine and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with HER2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.
|
|
12/09/2022
|
02/08/2022
|
delta-9-tetrahydrocannabinol and cannabidiol (Sativex)
|
Full
|
Indicated as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
|
|
12/09/2022
|
TBC
|
apalutamide (Erleada)
|
Full
|
In adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
|
|
12/09/2022
|
02/08/2022
|
velmanase alfa (Lamzede)
|
Ultra-orphan initial assessment
|
Enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.
|
|
12/09/2022
|
TBC
|
tofacitinib (Xeljenz)
|
Full
|
For treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy
|
|
12/09/2022
|
05/07/2022
|
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.
|
|
12/09/2022
|
05/07/2022
|
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.
|
|
10/10/2022
|
TBC
|
ozanimod (Zeposia)
|
Full
|
Treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy (CvT) or a biologic agent.
|
|
10/10/2022
|
|
brolucizumab (Beovu)
|
Abbreviated
|
in adults for the treatment of visual impairment due to diabetic macular oedema.
|
|
10/10/2022
|
|
upadacitinib (Rinvoq)
|
Abbreviated
|
Treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response or were intolerant to either conventional therapy (CT) or a biologic agent.
|
|
10/10/2022
|
06/09/2022
|
pembrolizumab (Keytruda)
|
Full
|
In combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease
|
|
10/10/2022
|
06/09/2022
|
pembrolizumab (Keytruda)
|
Full
|
Pembrolizumab in combination with lenvatinib, for the treatement of advanced or recurrent endometrial carcinoma (EC) in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation.
|
|
10/10/2022
|
06/09/2022
|
pembrolizumab (Keytruda)
|
Full
|
Pembrolizumab monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
|
|
10/10/2022
|
|
filgotinib (Jyseleca)
|
Resubmission
|
Treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate. (MTX).
|
|
07/11/2022
|
04/10/2022
|
asciminib (Scemblix)
|
Full
|
Treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors (TKIs).
|
|
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
|
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
|
semaglutide 2.4 mg (Wegovy)
|
Full
|
As an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of • ≥30 kg/m2 (obesity), or • ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity.
|
|