This is a summary of the European public assessment report (EPAR) for Revlimid. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Revlimid.
For practical information about using Revlimid, patients should read the package leaflet or contact their doctor or pharmacist.
Revlimid : EPAR - Summary for the public (PDF/88.84 KB)
First published: 14/08/2008
Last updated: 05/04/2017
Revlimid : EPAR - Risk-management-plan summary (PDF/215.88 KB)
First published: 23/08/2018
Last updated: 23/08/2018
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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.
Celgene Europe BV
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29/06/2018 Revlimid - EMEA/H/C/000717 - T/0101
- 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 in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Revlimid is indicated for the treatment of patients with transfusion-dependent anaemia 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 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