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LACOMED (Medsurge Pharma Pty Ltd)

Product name
LACOMED
Sponsor
Medsurge Pharma Pty Ltd
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.