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APO-SAFINAMIDE (Accelagen Pty Ltd)
Product name
APO-SAFINAMIDE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
133 (255 working days)
Active ingredients
safinamide mesilate
Registration type
New generic medicine
Indication
TRADENAME] is indicated for the treatment of adult patients with fluctuating idiopathic Parkinson’s disease (PD) as add-on therapy to a regimen that includes levodopa (L-Dopa).