DIACOMIT (Emerge Health Pty Ltd)
Product name
DIACOMIT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
242 working days (255)
Active ingredients
stiripentol
Registration type
NCE/NBE
Indication
DIACOMIT (capsule/powder for oral suspension) is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (SMEI, also known as Dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.