Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: Novartis Europharm Limited, Frimley Business Park, Camberley GU16 7SR, United Kingdom
Arzerra 100 mg concentrate for solution for infusion.
Arzerra 1000 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to opalescent, colourless to pale yellow liquid. |
One ml of concentrate contains 20 mg of ofatumumab.
Arzerra 100 mg concentrate for solution for infusion: Each vial contains 100 mg of ofatumumab in 5 ml.
Arzerra 1000 mg concentrate for solution for infusion: Each vial contains 1000 mg of ofatumumab in 50 ml.
Ofatumumab is a human monoclonal antibody produced in a recombinant murine cell line (NS0).
Excipient with known effect: This medicinal product contains 34.8 mg sodium per 300 mg dose, 116 mg sodium per 1000 mg dose and 232 mg sodium per 2000 mg dose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ofatumumab |
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. |
| List of Excipients |
|---|
|
Arginine |
Arzerra 100 mg concentrate for solution for infusion:
Clear Type I glass vial with a bromobutyl rubber stopper and aluminium over-seal, containing 5 ml of concentrate for solution for infusion.
Arzerra is available in packs of 3 vials.
Arzerra 1000 mg concentrate for solution for infusion:
Clear Type I glass vial with a bromobutyl rubber stopper and aluminium over-seal, containing 50 ml of concentrate for solution for infusion.
Arzerra is available in packs of 1 vial.
Novartis Europharm Limited, Frimley Business Park, Camberley GU16 7SR, United Kingdom
Arzerra 100 mg concentrate for solution for infusion: EU/1/10/625/001
Arzerra 1000 mg concentrate for solution for infusion: EU/1/10/625/003
Date of first authorisation: 19 April 2010
Date of latest renewal: 17 February 2015
| Drug | Countries | |
|---|---|---|
| ARZERRA | Estonia, Lithuania, United States |
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