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Zebinix
Published
Product name
Zebinix
Active ingredient
Eslicarbazepine acetate
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Zebinix (eslicarbazepine acetate) was approved for the following therapeutic use:
Zebinix is indicated as:
- monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;
- adjunctive therapy in adults, adolescents and children aged above 6 years, with partial- onset seizures with or without secondary generalisation.
How this medicine works
The precise mechanisms of action of eslicarbazepine acetate are unknown. However, in vitro electrophysiological studies indicate that both eslicarbazepine acetate and its metabolites stabilise the inactivated state of voltage gated sodium channels, precluding their return to the activated state and thereby preventing repetitive neuronal firing.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Zebinix was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
N/A
ARTG details: 335289 and 335290