Imnovid (previously Pomalidomide Celgene)

RSS

pomalidomide

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

Overview

This is a summary of the European public assessment report (EPAR) for Imnovid. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Imnovid.

For practical information about using Imnovid, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 16/11/2018

Authorisation details

Product details
Name
Imnovid (previously Pomalidomide Celgene)
Agency product number
EMEA/H/C/002682
Active substance
Pomalidomide
International non-proprietary name (INN) or common name
pomalidomide
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L04AX06
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 B.V. 
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
04/08/2013
Contact address

Celgene Europe B.V.
Winthontlaan 6 N
3526KV Utrecht
The Netherlands

Product information

28/09/2018 Imnovid (previously Pomalidomide Celgene) - EMEA/H/C/002682 - T/0030

Contents

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

Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
Average
1 rating
1 rating