Lenalidomide Accord

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lenalidomide

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 02/06/2021

Authorisation details

Product details
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
Anatomical therapeutic chemical (ATC) code
L04AX04
GenericGeneric

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
Marketing-authorisation holder
Accord Healthcare S.L.U.
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
20/09/2018
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

10/05/2021 Lenalidomide Accord - EMEA/H/C/004857 - IB/0011/G

Contents

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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).

Assessment history

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