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FINTEPLA (UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia)
Product name
FINTEPLA
Date registered
Evaluation commenced
Decision date
Approval time
202 (255 working days)
Active ingredients
fenfluramine hydrochloride
Registration type
EOI
Indication
Fintepla is indicated as add-on therapy in the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older.