Unituxin

RSS

dinutuximab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Unituxin has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 28/04/2017

Authorisation details

Product details
Name
Unituxin
Agency product number
EMEA/H/C/002800
Active substance
Dinutuximab
International non-proprietary name (INN) or common name
dinutuximab
Therapeutic area (MeSH)
Neuroblastoma
Anatomical therapeutic chemical (ATC) code
L01XC
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
United Therapeutics Europe Ltd
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
14/08/2015
Contact address
Uniter House
Curfew Bell Road
Chertsey
Surrey KT16 9FG
United Kingdom

Product information

20/03/2017 Unituxin - EMEA/H/C/002800 - PSUSA/10420/201608

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

ANTINEOPLASTIC AGENTS

Therapeutic indication

Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT). It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin.

Assessment history

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