Unituxin (dinutuximab)
- Region
- 🇪🇺 EU
- Active substance
- dinutuximab
- Company
- United Therapeutics Europe Ltd
- Status
- Withdrawn
- Therapeutic area
- Neuroblastoma
- CHMP opinion
- Thu 21 May 2015
- EU approval
- Fri 14 Aug 2015
- Application
- EMEA/H/C/002800
- ATC
- L01FX06
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) Authorised · Recordati Netherlands B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.