Basic Information
Zonisamide Viatris (previously Zonisamide Mylan)
Regulatory Information
EMEA/H/C/004127
March 31, 2016
January 28, 2016
11
January 27, 2025
Company Information
Ireland
Damastown Industrial Park Mulhuddart Dublin 15
MYLAN PHARMACEUTICALS PRIVATE LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication - Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; - adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.
Overview Summary
Zonisamide Viatris is a medicine used to treat patients with partial seizures (epileptic fits starting in one part of the brain), including those who have secondary generalisation (where the seizure subsequently spreads to the whole brain). It is used on its own in newly diagnosed adults and as an ‘add-on’ therapy in adults and children aged six years and above already receiving other anti-epilepsy medicines. Zonisamide Viatris contains the active substance zonisamide and is a ‘generic medicine’. This means that Zonisamide Viatris is similar to a ‘reference medicine’ already authorised in the EU called Zonegran. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf).