HSE - PCRS

Application Details

HSE Application ID

HSE100041

HTA Number

25030

HTA Link

https://www.ncpe.ie/sulthiame-ospolot-oral-suspension-hta-id-25030/

Drug

sulthiame

Brand

Ospolot®

Applicant

Desitin Arzneimittel GmbH

Indication Applied For

For the treatment of Self-Limited Epilepsy with Centrotemporal Spikes (SeLECTS) (former Rolandic epilepsy) in children and adolescents aged three years and above who are non-respondent/intolerant to other treatments or without other therapeutic alternatives.

Application Date

11/04/2025

Marketing Authorisation Date

25/10/2024

Application Status

Awaiting Proposal from Applicant

07/08/2025

Applicant Meeting Held with CPU

07/08/2025

Rapid Review Completed

27/05/2025

Rapid Review Commissioned

11/04/2025

Pricing and Reimbursement Application Complete

11/04/2025

New Search