Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)

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dinutuximab beta

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Qarziba. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Qarziba.

For practical information about using Qarziba, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 31/07/2018

Authorisation details

Product details
Name
Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
Agency product number
EMEA/H/C/003918
Active substance
dinutuximab beta
International non-proprietary name (INN) or common name
dinutuximab beta
Therapeutic area (MeSH)
Neuroblastoma
Anatomical therapeutic chemical (ATC) code
L01XC
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
EUSA Pharma (UK) Limited
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
08/05/2017
Contact address
Breakspear Park
Breakspear Way
Hemel Hempstead HP2 4TZ
United Kingdom

Product information

05/03/2018 Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) - EMEA/H/C/003918 - IB/0005

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTINEOPLASTIC AGENTS

Therapeutic 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 complete response after first line therapy, Qarziba should be combined with interleukin 2 (IL 2).

Assessment history

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