Revlimid

RSS

lenalidomide

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

Overview

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.

This EPAR was last updated on 23/08/2018

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 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.

Orphan

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
36
Date of issue of marketing authorisation valid throughout the European Union
14/06/2007
Contact address
Winthontlaan 6 N
3526KV Utrecht
Netherlands

Product information

29/06/2018 Revlimid - EMEA/H/C/000717 - T/0101

Contents

  • 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.

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 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 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.

Assessment history

Changes since initial authorisation of medicine

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