Ontozry (cenobamate)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- cenobamate
- Company
- Angelini Pharma S.p.A
- Status
- Authorised
- Therapeutic area
- Epilepsy
- EU approval
- Fri 26 Mar 2021
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005377
- ATC
- N03AX
- Official record
- www.ema.europa.eu
Indication
Adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.
Regulatory milestones
Tue 12 May 2026🇪🇺 DHPC safety letter
Ontozry (cenobamate): DHPC sent to healthcare professionals
Adverse event, Post-authorisation measure; Epilepsy · source
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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.