Diacomit

RSS

stiripentol

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 06/08/2014

Authorisation details

Product details
Name
Diacomit
Agency product number
EMEA/H/C/000664
Active substance
stiripentol
International non-proprietary name (INN) or common name
stiripentol
Therapeutic area (MeSH)
Myoclonic Epilepsy, Juvenile
Anatomical therapeutic chemical (ATC) code
N03AX17
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Biocodex
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
04/01/2007
Contact address
7 avenue Galliéni
F-94250 Gentilly
France

Product information

23/06/2014 Diacomit - EMEA/H/C/000664 - II/0016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTIEPILEPTICS

Therapeutic indication

Diacomit is indicated for use 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's syndrome) whose seizures are not adequately controlled with clobazam and valproate.

Assessment history

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