QARZIBA

This brand name is authorized in Austria, Croatia, Estonia, Finland, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Poland, Romania, Spain, UK.

Active ingredients

The drug QARZIBA contains one active pharmaceutical ingredient (API):

1
UNII 7SQY4ZUD30 - DINUTUXIMAB
 

Dinutuximab is a monoclonal chimeric antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG1 and light chain kappa. Dinutuximab reacts specifically with the ganglioside GD2, which is highly expressed on the surface of neuroblastoma cells and minimally expressed on the surface of normal human neurons, peripheral pain fibres, and skin melanocytes.

 
Read more about Dinutuximab

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 QARZIBA Concentrate for solution for infusion MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
L01FX06 Dinutuximab beta L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FX Other monoclonal antibodies
Discover more medicines within L01FX06

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
EE Ravimiamet 1744590
ES Centro de información online de medicamentos de la AEMPS 1171191001
FI Lääkealan turvallisuus- ja kehittämiskeskus 043759
GB Medicines & Healthcare Products Regulatory Agency 356560
HK Department of Health Drug Office 66900
IL מִשְׂרַד הַבְּרִיאוּת 8955
IT Agenzia del Farmaco 045427010
LT Valstybinė vaistų kontrolės tarnyba 1082908
PL Rejestru Produktów Leczniczych 100391925
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W66236001

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