|
SMC2893
|
13/04/2026
|
acalabrutinib (Calquence)
|
Abbreviated
|
In combination with venetoclax with or without obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
|
|
|
SMC2671
|
13/05/2024
|
zanubrutinib (Brukinsa)
|
Non submission
|
In combination with obinutuzumab for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
|
|
|
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).
|
|
|
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)
|
|
|
SMC2346
|
12/04/2021
|
acalabrutinib (Calquence)
|
Abbreviated
|
As monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)
|
|
|
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).
|
|
|
SMC2244
|
11/11/2019
|
ibrutinib (Imbruvica)
|
Non submission
|
In combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.
|
|
|
SMC2015
|
10/09/2018
|
obinutuzumab (Gazyvaro)
|
Resubmission
|
In combination with chemotherapy, followed by maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma (FL).
|
|
|
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.
|
|
|
1008/14
|
08/12/2014
|
obinutuzumab (Gazyvaro)
|
Full
|
In combination with chlorambucil, obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy.
|
|
