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GLATIRA, MULTIROS (Juno Pharmaceuticals Pty Ltd)
Product name
GLATIRA, MULTIROS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
168 working days (255)
Active ingredients
glatiramer acetate
Registration type
NCE/NBE
Indication
GLATIRA, MULTIROS (solution for injection) is indicated for 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.