Lenalidomide Accord
lenalidomide
Table of contents
Overview
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.
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Lenalidomide Accord : EPAR - Medicine overview (PDF/144.75 KB)
First published: 12/10/2018
Last updated: 17/02/2021
EMA/90018/2021 -
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Lenalidomide Accord : EPAR - Risk-management-plan summary (PDF/102.66 KB)
First published: 02/06/2021
Last updated: 31/03/2022
Authorisation details
Product details | |
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Name |
Lenalidomide Accord
|
Agency product number |
EMEA/H/C/004857
|
Active substance |
lenalidomide
|
International non-proprietary name (INN) or common name |
lenalidomide
|
Therapeutic area (MeSH) |
Multiple Myeloma
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Anatomical therapeutic chemical (ATC) code |
L04AX04
|
Generic |
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. |
Publication details | |
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Marketing-authorisation holder |
Accord Healthcare S.L.U.
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Revision |
9
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Date of issue of marketing authorisation valid throughout the European Union |
20/09/2018
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Contact address |
Accord Healthcare S.L.U. |
Product information
07/01/2022 Lenalidomide Accord - EMEA/H/C/004857 - IA/0018
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Immunosuppressants
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).