Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Qarziba   
Auth. number : EU/1/17/1191
Active substance : dinutuximab beta
Orphan market exclusivity for "Treatment of neuroblastoma" (based on designation EU/3/12/1062) started on 11/05/2017
   10 years of market exclusivity
   This orphan market exclusivity will expire on 11/05/2027
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC - Monoclonal antibodies
(See WHO ATC Index)
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).
Marketing Authorisation Holder: EUSA Pharma (Netherlands) B.V.
Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
11/05/2017 Centralised - Authorisation EMEA/H/C/3918 (2017)3193 of 8/05/2017
19/07/2017 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/3918/T/1 (2017)5168 of 17/07/2017
4/08/2017 Centralised - Variation EMEA/H/C/3918/IAIN/2
Updated with Decision(2018)4886 of 19/07/2018
27/11/2017 Centralised - Variation EMEA/H/C/3918/IAIN/3
Updated with Decision(2018)4886 of 19/07/2018
5/03/2018 Centralised - Variation EMEA/H/C/3918/IB/5
Updated with Decision(2018)4886 of 19/07/2018
23/07/2018 Centralised - Yearly update (2018)4886 of 19/07/2018
26/07/2018 Centralised - Annual reassessment EMEA/H/C/3918/S/6
12/03/2019 Centralised - Notification EMEA/H/C/3918/N/12
13/03/2019 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/3918/T/10 (2019)2061 of 11/03/2019