- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Unituxin has been withdrawn at the request of the marketing authorisation holder.
Unituxin : EPAR - Summary for the public
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Unituxin : EPAR - Risk-management-plan summary
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Product information
Unituxin : EPAR - Product Information
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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
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italiano (IT) (456.83 KB - PDF)
latviešu valoda (LV) (514.29 KB - PDF)
lietuvių kalba (LT) (492.43 KB - PDF)
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slovenščina (SL) (26.34 KB - PDF)
Suomi (FI) (453.8 KB - PDF)
svenska (SV) (457.32 KB - PDF)
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 agentsTherapeutic 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
English (EN) (527.07 KB - PDF)
Unituxin : EPAR - Public assessment report
English (EN) (6.29 MB - PDF)
CHMP summary of positive opinion for Unituxin
English (EN) (504.09 KB - PDF)
News on Unituxin
More information on Unituxin
Public statement on Unituxin: Withdrawal of the marketing authorisation in the European Union
English (EN) (66.47 KB - PDF)
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.