Imnovid (previously Pomalidomide Celgene)

pomalidomide

Opinion

On 28 March 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Imnovid. The marketing authorisation holder for this medicinal product is Celgene Europe BV.

The CHMP adopted an extension to the existing indication as follows:1

Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.

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.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold.

Key facts

Name
Imnovid (previously Pomalidomide Celgene)
Agency product number
EMEA/H/C/002682
International non-proprietary name (INN) or common name
  • pomalidomide
Active substance
  • Pomalidomide
Therapeutic area
Multiple Myeloma
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.

Date opinion adopted
28/03/2019
Company name
Celgene Europe B.V. 
Status
Positive
Application type
Post-authorisation

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