Lacosamide UCB

lacosamide

Opinion

On 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Lacosamide UCB. The marketing authorisation holder for this medicinal product is UCB Pharma S.A.

The CHMP adopted a new indication for the use of Lacosamide UCB as adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in patients from 4 years of age with idiopathic generalised epilepsy.

For information, the full indications for Lacosamide UCB will be as follows:*

Lacosamide UCB is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.

Lacosamide UCB is indicated as adjunctive therapy

  • in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
  • in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


* New text in bold

Key facts

Name
Lacosamide UCB
Agency product number
EMEA/H/C/005243
International non-proprietary name (INN) or common name
  • lacosamide
Active substance
  • lacosamide
Therapeutic area
Epilepsies, Partial
Date opinion adopted
15/10/2020
Company name
UCB Pharma S.A.
Status
Positive
Application type
Post-authorisation

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