This brand name is authorized in Estonia, Lithuania, United States
The drug ARZERRA contains one active pharmaceutical ingredient (API):
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1
Ofatumumab
UNII M95KG522R0 - OFATUMUMAB
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Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B-cell tumours. The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complement dependent cytotoxicity and resultant lysis of tumour cells. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| ARZERRA Concentrate for solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| L01FA02 | Ofatumumab | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FA CD20 (Clusters of Differentiation 20) inhibitors |
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): 1474376, 1515259 |
| Country: LT | Valstybinฤ vaistลณ kontrolฤs tarnyba | Identifier(s): 1054517, 1059538 |
| Country: US | FDA, National Drug Code | Identifier(s): 0078-0669, 0078-0690 |
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