Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Diacomit   
Auth. number : EU/1/06/367
Active substance : Stiripentol
Orphan market exclusivity for "Treatment of severe myoclonic epilepsy in infancy" (based on designation EU/3/01/071) started on 09/01/2007
   10 years of market exclusivity
   This orphan market exclusivity will expire on 09/01/2017
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N03 - Antiepileptics
Pharmacological subgroup: N03A - Antiepileptics
Chemical subgroup: N03AX - Other antiepileptics
Chemical substance: N03AX17 - Stiripentol
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Biocodex
7 avenue Gallieni, F-94250 Gentilly, France
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
09/01/2007 Centralised - Authorisation EMEA/H/C/664 (2007)30 of 04/01/2007
07/06/2007 Centralised - Notification EMEA/H/C/664/N/1
Updated with Decision(2007)6677 of 14/12/2007
18/12/2007 Centralised - Annual renewal EMEA/H/C/664/R/2 (2007)6677 of 14/12/2007
24/11/2008 Centralised - Annual renewal EMEA/H/C/664/R/3 (2008)7427 of 20/11/2008
30/01/2009 Centralised - Variation EMEA/H/C/664/II/4 (2009)595 of 28/01/2009
03/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/664/IA/5
01/12/2009 Centralised - Annual renewal EMEA/H/C/664/R/6 (2009)9598 of 26/11/2009
15/03/2010 Centralised - Variation EMEA/H/C/664/II/7 (2010)1657 of 11/03/2010
09/11/2010 Centralised - Variation EMEA/H/C/664/II/9 (2010)7832 of 05/11/2010
15/12/2010 Centralised - Annual renewal EMEA/H/C/664/R/8 (2010)9290 of 13/12/2010
24/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/664/IB/10/G
10/06/2011 Corrigendum (2011)4176 of 07/06/2011
17/01/2012 Centralised - Annual renewal EMEA/H/C/664/R/11 (2012)198 of 13/01/2012
20/08/2012 Centralised - Variation EMEA/H/C/664/IB/13
Updated with Decision(2012)8700 of 22/11/2012
26/11/2012 Centralised - Annual renewal EMEA/H/C/664/R/12 (2012)8700 of 22/11/2012
10/01/2014 Centralised - Authorisation - Switch to non-conditional EMEA/H/C/664/R/14 (2014)80 of 08/01/2014
25/06/2014 Centralised - 2-Monthly update EMEA/H/C/664/II/16 (2014)4367 of 23/06/2014