Zonegran (zonisamide)
- Region
- 🇪🇺 EU
- Active substance
- zonisamide
- Company
- Amdipharm Limited
- Status
- Authorised
- Therapeutic area
- Epilepsies, Partial
- CHMP opinion
- Wed 15 Dec 2004
- EU approval
- Thu 10 Mar 2005
- Application
- EMEA/H/C/000577
- ATC
- N03AX15
- Official record
- www.ema.europa.eu
Indication
Zonegran is indicated as: 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 six years and above.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Zonisamide Viatris (previously Zonisamide Mylan) Authorised · Viatris Limited
Follow Zonegran
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.