Thalidomide Celgene (previously Thalidomide Pharmion)

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thalidomide

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

Overview

This is a summary of the European public assessment report (EPAR) for Thalidomide Celgene. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Thalidomide Celgene.

This EPAR was last updated on 17/08/2018

Authorisation details

Product details
Name
Thalidomide Celgene (previously Thalidomide Pharmion)
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
Orphan

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
Celgene Europe BV 
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
16/04/2008
Contact address
Celgene Europe BV
Winthontlaan 6 N
3526 KV Utrecht
Netherlands

Product information

08/08/2018 Thalidomide Celgene (previously Thalidomide Pharmion) - EMEA/H/C/000823 - T/0057

Contents

  • 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

IMMUNOSUPPRESSANTS

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

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