Revlimid
lenalidomide
Table of contents
Overview
Revlimid is a medicine used for the treatment of certain cancers and serious conditions affecting blood cells and bone marrow, namely multiple myeloma, myelodysplastic syndromes and mantle cell and follicular lymphoma.
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 and follicular lymphoma, blood cancers that affect 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. In follicular lymphoma it is used with the medicine rituximab.
Revlimid contains the active substance lenalidomide.
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List item
Revlimid : EPAR - Medicine overview (PDF/170.73 KB)
First published: 14/08/2008
Last updated: 15/01/2020
EMA/13848/2020 -
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List item
Revlimid : EPAR - Risk Management Plan (PDF/4.66 MB)
First published: 06/12/2022
Authorisation details
Product details | |
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Name |
Revlimid
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Agency product number |
EMEA/H/C/000717
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Active substance |
lenalidomide
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International non-proprietary name (INN) or common name |
lenalidomide
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Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L04AX04
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Additional 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. |
Publication details | |
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Marketing-authorisation holder |
Bristol-Myers Squibb Pharma EEIG
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Revision |
49
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Date of issue of marketing authorisation valid throughout the European Union |
14/06/2007
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Contact address |
Plaza 254 |
Product information
14/10/2022 Revlimid - EMEA/H/C/000717 - II/0124
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
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.
Follicular lymphoma
Revlimid 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
News
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15/11/2019
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29/03/2019
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 201727/01/2017
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 January 201629/01/2016
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19/12/2014
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26/04/2013
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21/06/2012
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23/09/2011
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23/09/2011