This brand name is authorized in Austria, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom
The drug QARZIBA contains one active pharmaceutical ingredient (API):
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1
Dinutuximab beta
UNII 7SQY4ZUD30 - DINUTUXIMAB
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| QARZIBA Concentrate for solution for infusion | Medicines & Healthcare Products Regulatory Agency (GB) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| L01FX06 | Dinutuximab beta | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FX Other monoclonal antibodies |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: EE | Ravimiamet | Identifier(s): 1744590 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 1171191001 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 043759 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 356560 |
| Country: HK | Department of Health Drug Office | Identifier(s): 66900 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8955 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 045427010 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1082908 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100391925 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W66236001 |
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