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LACOMED (Medsurge Pharma Pty Ltd)
Product name
LACOMED
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
130 (255 working days)
Active ingredients
lacosamide
Registration type
New generic medicine
Indication
[TRADE NAME] (lacosamide) tablets and oral solution are indicated as:
- monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.
- add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older.
- add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.