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.
Lenalidomide Accord : EPAR - Medicine overview (PDF/144.75 KB)
First published: 12/10/2018
Last updated: 17/02/2021
Lenalidomide Accord : EPAR - Risk-management-plan summary (PDF/802.86 KB) (updated)
First published: 02/06/2021
Last updated: 02/06/2021
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
Accord Healthcare S.L.U.
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World Trade Center
10/05/2021 Lenalidomide Accord - EMEA/H/C/004857 - IB/0011/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.
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).