Imnovid (previously Pomalidomide Celgene)
pomalidomide
Table of contents
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.
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List item
Imnovid : EPAR - Medicine overview (PDF/75.85 KB)
First published: 13/08/2013
Last updated: 18/06/2019
EMA/240195/2019 -
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List item
Imnovid : EPAR - Risk Management Plan (PDF/12.64 MB) (updated)
First published: 29/06/2023
Last updated: 06/11/2023
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. |
Publication details | |
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Marketing-authorisation holder |
Bristol-Myers Squibb Pharma EEIG
|
Revision |
24
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Date of issue of marketing authorisation valid throughout the European Union |
05/08/2013
|
Contact address |
Plaza 254 |
Product information
25/08/2023 Imnovid (previously Pomalidomide Celgene) - EMEA/H/C/002682 - IB/0051
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.