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ZONEGRAN (zonisamide), antiepileptic

NEUROLOGY - New indication
Opinions on drugs - Posted on Apr 16 2015

Reason for request

Extension of inclusion

No clinical benefit demonstrated in the adjuvant treatment of partial epilepsy in children and adolescents over the age of 6 years compared with other antiepileptic drugs.

 

  • ZONEGRAN now has Marketing Authorisation in combination in the treatment of partial seizures with or without secondary generalisation in adolescents and children over the age of 6 years.
  • The response rate in children and adolescents at 12 weeks was higher with zonisamide than that observed with placebo.
  • This rate is close to the one obtained in adults.
  • The safety profile of ZONEGRAN in children and adolescents is similar to that observed in adults with however, in children, a greater incidence of pneumonia, dehydration, oligohidrosis and abnormal liver function.

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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