Thalidomide BMS (previously Thalidomide Celgene)

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thalidomide

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

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.

This EPAR was last updated on 01/07/2022

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
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
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

13/12/2021 Thalidomide BMS (previously Thalidomide Celgene) - EMEA/H/C/000823 - T/0073

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).

Assessment history

Changes since initial authorisation of medicine

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