Interferon Beta-1b

1). • patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years. • patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.

BETASERON (interferon beta-1b) is indicated for: • the treatment of patients with a single demyelinating event accompanied by at least two clinically silent lesions typical of multiple sclerosis (MS) on magnetic resonance imaging, to delay progression to definite MS.

Before initiating treatment with Betaseron, alternate diagnoses should first be excluded. • the reduction of the frequency of clinical exacerbations in ambulatory patients with relapsing- remitting multiple sclerosis. Relapsing-remitting MS is characterized by recurrent attacks of neurologic dysfunction followed by complete or incomplete recovery.

• the slowing of progression in disability and the reduction of the frequency of clinical exacerbations in patients with secondary-progressive multiple sclerosis. The safety and efficacy of Betaseron in primary progressive MS have not been evaluated.

1 Pediatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (> 65 years of age): The safety and efficacy of Betaseron in patients > 65 years of age has not been established.

1). • patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years. • patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.