Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Matever   
Auth. number : EU/1/11/711
Active substance : levetiracetam
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N03 - Antiepileptics
Pharmacological subgroup: N03A - Antiepileptics
Chemical subgroup: N03AX - Other antiepileptics
Chemical substance: N03AX14 - Levetiracetam
(See WHO ATC Index)
Indication: Matever is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Matever is indicated as adjunctive therapy- in the treatment of partial onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy.- in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.- in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Marketing Authorisation Holder: Pharmathen S.A.
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα
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
06/10/2011 Centralised - Authorisation EMEA/H/C/2024 (2011)7182 of 03/10/2011
28/11/2011 Centralised - Notification EMEA/H/C/2024/N/1
Updated with Decision(2012)6967 of 28/09/2012
04/04/2012 Centralised - Variation EMEA/H/C/2024/IB/3
Updated with Decision(2012)6967 of 28/09/2012
22/05/2012 Centralised - Notification EMEA/H/C/2024/N/4
Updated with Decision(2012)6967 of 28/09/2012
24/08/2012 Centralised - Variation EMEA/H/C/2024/IB/6
Updated with Decision(2012)6967 of 28/09/2012
03/10/2012 Centralised - Variation (2012)6967 of 28/09/2012
06/02/2013 Centralised - Notification EMEA/H/C/2024/N/8
Updated with Decision(2015)209 of 15/01/2015
21/05/2013 Centralised - Notification EMEA/H/C/2024/N/9
Updated with Decision(2015)209 of 15/01/2015
28/08/2013 Centralised - Notification EMEA/H/C/2024/N/10
Updated with Decision(2015)209 of 15/01/2015
19/12/2013 Centralised - Variation EMEA/H/C/2024/IB/13
Updated with Decision(2015)209 of 15/01/2015
01/04/2014 Centralised - Notification EMEA/H/C/2024/N/15
Updated with Decision(2015)209 of 15/01/2015
05/05/2014 Centralised - Variation EMEA/H/C/2024/IB/16
Updated with Decision(2015)209 of 15/01/2015
02/10/2014 Centralised - Notification EMEA/H/C/2024/N/17
Updated with Decision(2015)209 of 15/01/2015
19/01/2015 Centralised - Yearly update (2015)209 of 15/01/2015
26/02/2015 Centralised - Notification EMEA/H/C/2024/N/20