Generic name |
interferon beta-1b |
|
---|---|---|
Strength |
0.3 mg |
|
Form |
single-use vial (Extavia®/Betaseron®) |
Special Authority criteria |
Approval period |
---|---|
Initial: As first-line monotherapy for the treatment of relapsing-remitting multiple sclerosis (MS) or secondary progressive 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:
|
15 months |
Renewal: As monotherapy, when prescribed by a neurologist from a designated MS clinic for the treatment of patients with relapsing-remitting MS or secondary progressive MS, 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 therapy: As monotherapy, when prescribed by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS or secondary progressive MS, AND who have experienced failure or intolerance to a previous disease modifying therapy. |
15 months |