Kigabeq (vigabatrin)
- Region
- 🇪🇺 EU
- Active substance
- vigabatrin
- Company
- Orphelia Pharma S.A.S.
- Status
- Authorised
- Therapeutic area
- Spasms, Infantile; Epilepsies, Partial
- CHMP opinion
- Thu 28 Jun 2018
- EU approval
- Thu 20 Sep 2018
- Application
- EMEA/H/C/004534
- ATC
- N03AG04
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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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.