Thalidomide Celgene (previously Thalidomide Pharmion)



This medicine is authorised for use in the European Union.


Thalidomide Celgene 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 Celgene 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.

This EPAR was last updated on 29/07/2021

Authorisation details

Product details
Thalidomide Celgene (previously Thalidomide Pharmion)
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Celgene Europe BV 
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Winthontlaan 6 N
3526 KV Utrecht

Product information

16/07/2021 Thalidomide Celgene (previously Thalidomide Pharmion) - EMEA/H/C/000823 - PSUSA/00002919/202010


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group


Therapeutic indication

Thalidomide Celgene 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 Celgene is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating