🇪🇺 DINUTUXIMAB BETA in European Union

EMA authorised DINUTUXIMAB BETA on 8 May 2017

Marketing authorisation

Application: EMEA/H/C/003918
Marketing authorisation holder: Recordati Netherlands B.V.
Local brand name: Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
Indication: Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a
Pathway: exceptional circumstances, orphan
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is DINUTUXIMAB BETA approved in European Union?

Yes. EMA authorised it on 8 May 2017.

Who is the marketing authorisation holder for DINUTUXIMAB BETA in European Union?

Recordati Netherlands B.V. holds the EU marketing authorisation.