Unituxin

dinutuximab

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The marketing authorisation for Unituxin has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Unituxin : EPAR - Summary for the public BG = bălgarski 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public ES = español 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public CS = čeština 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public DA = dansk 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public DE = Deutsch 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public ET = eesti keel 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public EL = elliniká 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public FR = français 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public IT = italiano 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public LV = latviešu valoda 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public LT = lietuvių kalba 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public HU = magyar 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public MT = Malti 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public NL = Nederlands 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public PL = polski 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public PT = português 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public RO = română 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public SK = slovenčina 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public SL = slovenščina 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public FI = suomi 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public SV = svenska 2015-09-01 2017-04-28
Unituxin : EPAR - Summary for the public HR = Hrvatski 2015-09-01 2017-04-28
Name Language First published Last updated
Unituxin : EPAR - Risk-management-plan summary (English only) 2015-09-01 2017-04-28

This EPAR was last updated on 28/04/2017 .

Authorisation details

Product details

Product details for Unituxin
NameUnituxin
Agency product numberEMEA/H/C/002800
Active substance

dinutuximab

International non-proprietary name (INN) or common name

dinutuximab

Therapeutic area Neuroblastoma
Anatomical therapeutic chemical (ATC) code L01XC
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Unituxin
Marketing-authorisation holder

United Therapeutics Europe Ltd

Revision3
Date of issue of marketing authorisation valid throughout the European Union14/08/2015

Contact address:

United Therapeutics Europe Ltd
Uniter House 
Curfew Bell Road 
Chertsey 
Surrey KT16 9FG 
United Kingdom

Product information

Product information

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

Name Language First published Last updated
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - Product Information EN = English 2015-09-01 2017-04-28

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.


Name Language First published Last updated
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28
Unituxin : EPAR - All Authorised presentations EN = English 2015-09-01 2017-04-28

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Unituxin : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-08-04 2017-04-28

Initial marketing-authorisation documents

Name Language First published Last updated
Unituxin : EPAR - Public assessment report EN = English 2015-09-01 2017-04-28
CHMP summary of positive opinion for Unituxin EN = English 2015-05-22 2017-04-28

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Unituxin