Lenalidomide Mylan is a medicine used for the treatment of certain cancers affecting blood cells, namely multiple myeloma and follicular lymphoma.
In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide Mylan is used:
- in adults with previously untreated (newly diagnosed) multiple myeloma, 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 stem cell transplantation. 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, a blood cancer that affects a type of white blood cell called B lymphocytes, Lenalidomide Mylan is used in adults whose disease has come back after treatment or does not improve with treatment. It is used in combination with rituximab.
Lenalidomide Mylan contains the active substance lenalidomide and is a ‘generic medicine’. This means that Lenalidomide Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Revlimid.
Lenalidomide Mylan : EPAR - Medicine overview (PDF/169.87 KB)
First published: 07/01/2021
Lenalidomide Mylan : EPAR - Risk-management-plan summary (PDF/161.9 KB)
First published: 07/01/2021
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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.
Mylan Ireland Limited
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05/03/2021 Lenalidomide Mylan - EMEA/H/C/005306 - IA/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 Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.
Lenalidomide Mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Lenalidomide Mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Lenalidomide Mylan in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1-3a).