Revlimid

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lenalidomide

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

Overview

Revlimid is a medicine used for the treatment of multiple myeloma, myelodysplastic syndromes and mantle cell lymphoma, which are conditions affecting blood cells and bone marrow.

In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Revlimid 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 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 myelodysplastic syndromes, a group of bone marrow disorders that cause anaemia (low red blood cell counts), Revlimid is used in patients who need blood transfusions to manage their anaemia. It is used in patients with a genetic abnormality (called deletion 5q) when other treatments are not adequate.

In mantle cell lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes, Revlimid is used in adults whose disease has come back after treatment or does not improve with treatment.

These diseases are rare, and Revlimid was designated an ‘orphan medicine’ (a medicine used in rare diseases) on various dates. Further information on the orphan designations can be found on the European Medicines Agency’s website (myelodysplastic syndromes: 8 March 2004; mantle cell lymphoma: 27 October 2011); Revlimid's orphan designation for multiple myeloma (12 December 2003) has now expired.

Revlimid contains the active substance lenalidomide.

This EPAR was last updated on 11/06/2019

Authorisation details

Product details
Name
Revlimid
Agency product number
EMEA/H/C/000717
Active substance
lenalidomide
International non-proprietary name (INN) or common name
lenalidomide
Therapeutic area (MeSH)
  • Multiple Myeloma
  • Lymphoma, Mantle-Cell
  • Myelodysplastic Syndromes
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.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Celgene Europe BV
Revision
38
Date of issue of marketing authorisation valid throughout the European Union
14/06/2007
Contact address
Winthontlaan 6 N
3526KV Utrecht
Netherlands

Product information

13/05/2019 Revlimid - EMEA/H/C/000717 - II/0102/G

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Multiple myeloma

Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

Revlimid 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.

Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

Myelodysplastic syndromes

Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

Mantle cell lymphoma

Revlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

Assessment history

Changes since initial authorisation of medicine

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