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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 |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
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