Imnovid (previously Pomalidomide Celgene)

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pomalidomide

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

Overview

Imnovid is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow). It is used in combination with bortezomib (another cancer medicine) and dexamethasone (an anti-inflammatory medicine) in adults who have received at least one treatment including lenalidomide (another cancer medicine).

It is also used in combination with dexamethasone in adults who have received at least two prior therapies, including both lenalidomide and bortezomib, and whose disease has worsened.

Imnovid contains the active substance pomalidomide.

Multiple myeloma is rare, and Imnovid was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 October 2009. Further information on the orphan designation can be found on ema.europa.eu/medicines/human/orphan-designations/EU309672.

This EPAR was last updated on 10/01/2022

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 monitoringAdditional 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.

OrphanOrphan

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
Bristol-Myers Squibb Pharma EEIG
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
05/08/2013
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

09/12/2021 Imnovid (previously Pomalidomide Celgene) - EMEA/H/C/002682 - PSUSA/00010127/202102

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Product information documents contain:

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

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.

Assessment history

Changes since initial authorisation of medicine

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