Kigabeq

RSS

vigabatrin

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

Overview

Kigabeq is a medicine for treating epilepsy in children between 1 month and 7 years of age. It is used in the following ways:

  • on its own to treat infantile spasms (West syndrome), a rare epilepsy disorder that starts at a very young age, usually in the first few months of life;
  • together with other medicines to treat partial epilepsy (seizures affecting one part of the brain), including when the seizures spread to other parts of the brain and become more generalised. Kigabeq is only used in partial epilepsy when patients have already tried all other appropriate treatments or cannot use them because of side effects.

Kigabeq contains the active substance vigabatrin and is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but Kigabeq is available in a different form and strengths. The reference medicine for Kigabeq is Sabril (500 mg granules).

This EPAR was last updated on 14/02/2019

Authorisation details

Product details
Name
Kigabeq
Agency product number
EMEA/H/C/004534
Active substance
vigabatrin
International non-proprietary name (INN) or common name
vigabatrin
Therapeutic area (MeSH)
  • Spasms, Infantile
  • Epilepsies, Partial
Anatomical therapeutic chemical (ATC) code
N03AG04
Publication details
Marketing-authorisation holder
ORPHELIA Pharma SAS
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
20/09/2018
Contact address

85 Boulevard Saint-Michel
75005 Paris
France

Product information

22/01/2019 Kigabeq - EMEA/H/C/004534 - IB/0001

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Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for:

  • Treatment in monotherapy of infantile spasms (West's syndrome).
  • Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.

Assessment history

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