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 25/08/2023

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
Publication details
Marketing-authorisation holder
Biocodex
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
03/01/2007
Contact address
7 avenue Galliéni
F-94250 Gentilly
France

Product information

25/04/2023 Diacomit - EMEA/H/C/000664 - N/0044

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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