GLATIRAMER VIATRIS (Alphapharm Pty Ltd)
Product name
GLATIRAMER VIATRIS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
163 (255 working days)
Active ingredients
glatiramer acetate
Registration type
New generic medicine
Indication
GLATIRAMER VIATRIS (solution for injection) is indicated for the reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis.
Treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent MRI lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.