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Ofatumumab
Trade Name:
Arzerra
Manufacturer/Distributor:
GlaxoSmithKline
www.gsk.ca 1-800-387-7374
Classification:
Antineoplastic agent
ATC Class:
L01XC10 - ofatumumab
Status:
active
Notice of Compliance (yyyy/mm/dd):
2012/03/09
Date Marketed in Canada (yyyy/mm/dd):
2012/03/09
Presentation:
Injection: 100 mg/5 mL. DIN: 02381559
Injection: 1000 mg/50 mL. DIN: 02381567
Comments:
Ofatumumab is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. It has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization.
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