Ontozry

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cenobamate

Authorised
This medicine is authorised for use in the European Union.

Overview

Ontozry is an epilepsy medicine for treating epileptic fits starting in one specific part of the brain (focal seizures), including those that eventually spread to the whole brain (secondary generalisation).

Ontozry is used as an add-on to other epilepsy medicines for adults with seizures that are not controlled despite having tried at least two other treatments.

It contains the active substance cenobamate.

This EPAR was last updated on 08/09/2022

Authorisation details

Product details
Name
Ontozry
Agency product number
EMEA/H/C/005377
Active substance
cenobamate
International non-proprietary name (INN) or common name
cenobamate
Therapeutic area (MeSH)
Epilepsy
Anatomical therapeutic chemical (ATC) code
N03AX
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Angelini Pharma S.p.A
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
26/03/2021
Contact address
Angelini Pharma S.p.A
Viale Amelia 70, 00181
Rome – Italy

Product information

07/07/2022 Ontozry - EMEA/H/C/005377 - II/0009

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antiepileptics

Therapeutic 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.

Assessment history

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