Vigabatrin (1) – Kigabeq®

• Clinical trials
  • At the relevant time, the pharmaceutical manufacturer had not submitted a complete dossier in accordance with Chapter 5, Section 8(1) in conjunction with Section 11(1), first sentence, of the VerfO.

Children aged from 1 month to under 7 years with treatment-resistant partial epilepsy (focal seizures), with or without secondary generalisation, for whom all other suitable combinations of medicinal products have proved inadequate or have not been tolerated

• As the required proof has not been submitted, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code [SGB V]).
• No dossier was submitted by the pharmaceutical manufacturer at the relevant time. Pursuant to Section 35a(1), fifth sentence, of SGB V, this means that no assessment will be carried out as to whether, or to what extent, the active ingredient (INN) vigabatrin, in the therapeutic indication ‘children aged from 1 month to under 7 years with treatment-resistant partial epilepsy (focal seizures) with or without secondary generalisation, in whom all other suitable combinations of medicinal products have proved inadequate or have not been tolerated’, the active substance vigabatrin offers any additional benefit compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.