Lenalidomide Accord is a medicine used for the treatment of multiple myeloma, a cancer of a type of white blood cells called plasma cells. Lenalidomide Accord is used:
- on its own, 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) to stop the progression of the cancer;
- in combination with dexamethasone (an anti-inflammatory medicine), for the treatment of adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have a stem cell transplant;
- in combination with melphalan (a cancer medicine) and prednisone (an anti-inflammatory medicine) for the treatment of adults with previously untreated multiple myeloma, who cannot have a stem cell transplant;
- in combination with dexamethasone, in adults whose disease has been treated at least once in the past.
Lenalidomide Accord contains the active substance lenalidomide and 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.
Lenalidomide Accord : EPAR - Medicine overview (PDF/93.96 KB)
First published: 12/10/2018
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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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01/03/2019 Lenalidomide Accord - EMEA/H/C/004857 - T/0001
- 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
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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 (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.