Unituxin
Withdrawn
This medicine's authorisation has been withdrawn
dinutuximab
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 20 March 2017, the European Commission withdrew the marketing authorisation for Unituxin (dinutuximab) in the European Union (EU). The withdrawal was initiated by the marketing authorisation holder (MAH), United Therapeutics Europe Ltd, which had requested the European Commission to withdraw the marketing authorisation due to short- and intermediate- term inability to supply Unituxin in sufficient quantities for meeting current global demands.
The MAH has confirmed that it has no future plans to commercialise Unituxin in the EU until the supply issues have been resolved. Unituxin was granted marketing authorisation in the EU on 14 August 2015 for the treatment of highrisk neuroblastoma. The marketing authorisation was initially valid for a 5-year period. The MAH has confirmed that any neuroblastoma patients who are currently receiving Unituxin treatment will have the possibility to receive the full treatment until completion of the 5 courses. No new patients with high risk neuroblastoma will be started on Unituxin therapy due to the lack of drug supply.
The European Public Assessment Report (EPAR) for Unituxin is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:PSUSA/10420/201608
20/03/2017
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).
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.
News on Unituxin
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