Thalidomide BMS (previously Thalidomide Celgene)
thalidomide
Table of contents
Overview
Thalidomide BMS1 is used to treat multiple myeloma (a cancer of the bone marrow) in combination with the cancer medicines melphalan and prednisone in patients who have not been treated for multiple myeloma before. It is used in patients aged 65 years or over, and in younger patients if they cannot be treated with high-dose chemotherapy.
Thalidomide BMS must be prescribed and dispensed according to a special programme put in place to prevent the exposure of unborn children to the medicine.
It contains the active substance thalidomide.
1Initially known as Thalidomide Pharmion and subsequently as Thalidomide Celgene.
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Thalidomide BMS (previously Thalidomide Celgene) : EPAR - Medicine overview (PDF/146.02 KB)
First published: 26/02/2009
Last updated: 30/06/2022
EMA/58328/2022 -
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Thalidomide Celgene : EPAR - Risk-management-plan summary (PDF/309.4 KB)
First published: 13/05/2019
Authorisation details
Product details | |
---|---|
Name |
Thalidomide BMS (previously Thalidomide Celgene)
|
Agency product number |
EMEA/H/C/000823
|
Active substance |
Thalidomide
|
International non-proprietary name (INN) or common name |
thalidomide
|
Therapeutic area (MeSH) |
Multiple Myeloma
|
Anatomical therapeutic chemical (ATC) code |
L04AX02
|
Publication details | |
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Marketing-authorisation holder |
Bristol-Myers Squibb Pharma EEIG
|
Revision |
30
|
Date of issue of marketing authorisation valid throughout the European Union |
16/04/2008
|
Contact address |
Plaza 254 |
Product information
13/12/2021 Thalidomide BMS (previously Thalidomide Celgene) - EMEA/H/C/000823 - T/0073
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
Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy.
Thalidomide BMS is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).