Basic Information
Lenalidomide Accord
Regulatory Information
EMEA/H/C/004857
September 20, 2018
July 26, 2018
12
July 2, 2024
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication **Multiple myeloma** Lenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. **Follicular lymphoma** Lenalidomide Accord in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
Overview Summary
Lenalidomide Accord is a medicine used for the treatment of multiple myeloma (cancer of a type of white blood cells called plasma cells) and follicular lymphoma (cancer of another type of white blood cells called B lymphocytes). In multiple myeloma, Lenalidomide Accord is used: - in adults who have had a stem cell transplant (a procedure where the patient’s bone marrow is cleared of cells and replaced by stem cells from a donor); - in adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have a stem cell transplant. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone; - in adults whose disease has been treated at least once. It is used in combination with dexamethasone. In follicular lymphoma, Lenalidomide Accord is used in adults who have already been treated for their disease. It is used with the medicine rituximab. Lenalidomide Accord is a ‘generic medicine’. This means that Lenalidomide Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Revlimid. For more information on generic medicines, see the question-and-answer document below.