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.
Revlimid : EPAR - Medicine overview (PDF/105.33 KB)
First published: 14/08/2008
Last updated: 11/06/2019
Revlimid : EPAR - Risk-management-plan summary (PDF/206.5 KB)
First published: 23/08/2018
Last updated: 11/06/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Celgene Europe BV
|Date of issue of marketing authorisation valid throughout the European Union||
13/05/2019 Revlimid - EMEA/H/C/000717 - II/0102/G
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 201727/01/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 January 201629/01/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 December 201419/12/2014
Celgene Europe Limited withdraws its application for an extension of the indication for Revlimid (lenalidomide)21/06/2012
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 September 201123/09/2011