|
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.
|
|
|
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.
|
|
|
1037/15
|
11/05/2015
|
ofatumumab (Arzerra)
|
Full
|
in combination with chlorambucil or bendamustine is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.
|
|
|
701/11
|
11/04/2011
|
bendamustine (Levact)
|
Non submission
|
Indolent non-Hodgkin's lymphomas as monotherapy in patients who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen.
|
|
|
700/11
|
11/04/2011
|
bendamustine (Levact)
|
Non submission
|
for the front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.
|
|
|
694/11
|
10/04/2011
|
bendamustine hydrochloride (Levact)
|
Full
|
Chronic Lymphocytic Leukaemia (CLL)
|
|
