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, 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. 

This EPAR was last updated on 15/04/2019

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
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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
1
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

01/03/2019 Lenalidomide Accord - EMEA/H/C/004857 - T/0001

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Pharmacotherapeutic group

IMMUNOSUPPRESSANTS

Therapeutic indication

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.

Assessment history

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