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Zonisamide Viatris (previously Zonisamide Mylan) (zonisamide)

Generic
Region
🇪🇺 EU
Active substance
zonisamide
Company
Viatris Limited
Status
Authorised
Therapeutic area
Epilepsy
CHMP opinion
Thu 28 Jan 2016
EU approval
Thu 31 Mar 2016
Designations
Generic
Application
EMEA/H/C/004127
ATC
N03AX15
Official record
www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.