|
SMC2955
|
10/08/2026
|
zilucoplan (Zilbrysq)
|
Resubmission
|
As an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti‑acetylcholine receptor (AChR) antibody positive.
|
|
|
SMC2846
|
13/07/2026
|
glofitamab (Columvi)
|
Full
|
In combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).
|
|
|
SMC2943
|
08/06/2026
|
tafasitamab (Minjuvi)
|
Non submission
|
Tafasitamab is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.
|
|
|
SMC2578
|
13/11/2023
|
avacopan (Tavneos)
|
Full
|
In combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
|
|
|
SMC2524
|
10/07/2023
|
polatuzumab vedotin (Polivy)
|
Reassessment
|
In combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.
|
|
|
SMC2525
|
12/06/2023
|
polatuzumab vedotin (Polivy)
|
Full
|
In combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
|
|
|
SMC2427
|
09/05/2022
|
venetoclax (Venclyxto)
|
Full
|
In combination with obinutuzumab (VenG) is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
|
|
|
SMC2485
|
11/04/2022
|
ibrutinib (Imbruvica)
|
Non submission
|
In combination with rituximab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.
|
|
|
SMC2365
|
13/09/2021
|
filgotinib (Jyseleca)
|
Full
|
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). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX).
|
|
|
SMC2347
|
07/06/2021
|
acalabrutinib (Calquence)
|
Full
|
As monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)
|
|
|
SMC2315
|
08/02/2021
|
upadacitinib (Rinvoq)
|
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.
|
|
|
SMC2293
|
07/12/2020
|
venetoclax (Venclyxto)
|
Full
|
In combination with obinutuzumab (VenG) is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
|
|
|
SMC2259
|
12/10/2020
|
ibrutinib (Imbruvica)
|
Full
|
In combination with rituximab for the treatment of adult patients with Waldenström's macroglobulinaemia.
|
|
|
SMC2281
|
12/10/2020
|
lenalidomide (Revlimid)
|
Full
|
In combination with rituximab (anti-CD20 antibody) for the treatment of adult patients with previously treated Follicular Lymphoma (Grade 1 - 3a).
|
|
|
SMC2166
|
12/08/2019
|
venetoclax (Venclyxto)
|
Full
|
In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
|
|
|
SMC2193
|
13/05/2019
|
rituximab (MabThera)
|
Non submission
|
Treatment of patients with moderate to severe pemphigus vulgaris.
|
|
|
SMC2165
|
11/03/2019
|
rituxumab (MabThera)
|
Non submission
|
In combination with glucocorticoids, for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).
|
|
|
1314/18
|
09/04/2018
|
sarilumab (Kevzara)
|
Full
|
In combination with methotrexate, or as monontherapy, for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs. Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.
|
|
|
1258/17
|
12/06/2017
|
ibrutinib (Imbruvica)
|
Non submission
|
In combination with bendamustine and rituximab for the treatment of adult patients with chronic lymphocytic leukaemia who have received at least one prior therapy.
|
|
|
1219/17
|
13/03/2017
|
obinutuzumab (Gazyvaro)
|
Full
|
In combination with bendamustine followed by obinutuzumab maintenance is indicated for the treatment of patients with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with rituximab or a rituximab-containing regimen.
|
|
