following an abbreviated submission:
Indication under review: 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.
SMC restriction: patients in whom other formulations of vigabatrin are not suitable.
Vigabatrin 500mg soluble tablets are considered bioequivalent to vigabatrin 500mg granules for oral solution. Vigabatrin soluble tablets are more expensive than vigabatrin granules for oral solution. Overall net budget impact is likely to be small.
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Medicine details
- Medicine name:
- vigabatrin (Kigabeq)
- SMC ID:
- SMC2352
- Indication:
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.- Pharmaceutical company
- Veriton Pharma
- BNF chapter
- Central nervous system
- Submission type
- Abbreviated
- Status
- Restricted
- Date advice published
- 07 June 2021