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stiripentol (Diacomit®)


Reference No. 3468


Appraisal information

stiripentol (Diacomit®) capsule


Company: Biocodex
BNF category: Central nervous system
NMG meeting date: 04/10/2017
AWMSG meeting date: 08/11/2017
   
   
Submission Type: Resubmission
Status: In progress
Advice No: Not available
Ministerial ratification: Not available

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification

Indication

In conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI; Dravet syndrome) whose seizures are not adequately controlled with clobazam and valproate
Preliminary Appraisal Recommendation (PAR)
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Company Response to the Preliminary Appraisal Recommendation (CR PAR)
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AWMSG Secretariat Appraisal Report (ASAR)
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Clinical Expert (CE) Summary
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