Overview

The marketing authorisation for Unituxin has been withdrawn at the request of the marketing authorisation holder.

Unituxin : EPAR - Summary for the public

Reference Number: EMA/364550/2015

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svenska (SV) (515.89 KB - PDF)

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Unituxin : EPAR - Risk-management-plan summary

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Product information

Unituxin : EPAR - Product Information

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latviešu valoda (LV) (1.33 MB - PDF)

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svenska (SV) (756.97 KB - PDF)

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Latest procedure affecting product information: PSUSA/10420/201608

20/03/2017

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This medicine’s product information is available in all official EU languages.
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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).

Unituxin : EPAR - All Authorised presentations

English (EN) (454.19 KB - PDF)

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български (BG) (515.95 KB - PDF)

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español (ES) (457.14 KB - PDF)

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čeština (CS) (505.78 KB - PDF)

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dansk (DA) (457.1 KB - PDF)

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Deutsch (DE) (919.01 KB - PDF)

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eesti keel (ET) (453.87 KB - PDF)

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ελληνικά (EL) (513.19 KB - PDF)

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français (FR) (454.77 KB - PDF)

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íslenska (IS) (456.85 KB - PDF)

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italiano (IT) (456.83 KB - PDF)

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latviešu valoda (LV) (514.29 KB - PDF)

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lietuvių kalba (LT) (492.43 KB - PDF)

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Nederlands (NL) (457.11 KB - PDF)

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norsk (NO) (456.4 KB - PDF)

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polski (PL) (508.72 KB - PDF)

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português (PT) (454.32 KB - PDF)

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română (RO) (496.73 KB - PDF)

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slovenčina (SK) (957.17 KB - PDF)

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slovenščina (SL) (26.34 KB - PDF)

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Suomi (FI) (453.8 KB - PDF)

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svenska (SV) (457.32 KB - PDF)

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Product details

Name of medicine
Unituxin
Active substance
Dinutuximab
International non-proprietary name (INN) or common name
dinutuximab
Therapeutic area (MeSH)
Neuroblastoma
Anatomical therapeutic chemical (ATC) code
L01FX06

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.

Authorisation details

EMA product number
EMEA/H/C/002800
Marketing authorisation holder
United Therapeutics Europe Ltd

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

Opinion adopted
21/05/2015
Marketing authorisation issued
14/08/2015
Revision
3

Assessment history

Unituxin : EPAR - Procedural steps taken and scientific information after authorisation

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Unituxin : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/408316/2015

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CHMP summary of positive opinion for Unituxin

AdoptedReference Number: EMA/CHMP/303761/2015

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More information on Unituxin

Public statement on Unituxin: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMEA/H/C/002800

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This product was originally designated an orphan medicine on 21 June 2011. Unituxin was withdrawn from the Community register of orphan medicinal products by the European Commission in March 2017 at the time of the withdrawal of the marketing authorisation. 

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