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LACOSAMIDE SANDOZ (Sandoz Pty Ltd)
Product name
LACOSAMIDE SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
152 (255 working days)
Active ingredients
lacosamide
Registration type
New generic medicine
Indication
LACOSAMIDE SANDOZ (film coated tablets) are indicated for monotherapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.
Add-on therapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older.
Paediatric patents weighing less than 50 kg should not receive Lacosamide Sandoz film-coated tablets. Paediatric patients weighing less than 50 kg should be accurately dosed on a mg/kg basis with other lacosamide products.