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Active Substance: dinutuximab
Common Name: dinutuximab
ATC Code: L01XC
Marketing Authorisation Holder: United Therapeutics Europe Ltd
Active Substance: dinutuximab
Status: Withdrawn
Authorisation Date: 2015-08-14
Therapeutic Area: Neuroblastoma
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.

The marketing authorisation for Unituxin has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

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