Generic name |
teriflunomide (Aubagio®) |
---|---|
Strength |
14 mg |
Form |
film-coated tablet |
Special Authority criteria |
Approval period |
---|---|
Initial As 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:
|
15 months |
Renewal As first-line or second-line monotherapy, when prescribed by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting 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 second-line monotherapy, when prescribed by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS who have experienced failure or intolerance to a previous disease-modifying therapy. |
15 months |
Generic Transition Support