Return to Special Authority drug list
Generic name |
dimethyl fumarate |
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Strength & form |
120 mg, 240 mg delayed-release capsule |
Special Authority criteria |
Approval period |
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InitialAs first-line monotherapy for the treatment of relapsing-remitting multiple sclerosis (MS) diagnosed according to the current clinical criteria and magnetic resonance imaging (MRI) evidence, when prescribed by a neurologist from a designated MS clinic, for patients who meet ALL of the following criteria: Patient is ambulatory with or without aid (EDSS of 6.5 or less) AND Patient is 18 years of age or older |
15 months |
RenewalAs monotherapy, when prescribed by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS (RRMS), AND who have demonstrated that the therapeutic benefits outweigh any potential risks, as shown by relapse rate, EDSS, MRI scan, or overall clinical impression |
24 months |
Change of therapyAs monotherapy, when prescribed by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS (RRMS) who have experienced failure or intolerance to a previous disease-modifying therapy |
15 months |