Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Levetiracetam Actavis   
Auth. number : EU/1/11/713
INN : 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: Levetiracetam Actavis 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.Levetiracetam Actavis 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: Actavis Group PTC ehf.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

  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
05/10/2011 Centralised - Authorisation EMEA/H/C/2355 (2011)7181 of 03/10/2011
16/05/2012 Centralised - Variation EMEA/H/C/2355/IB/2
Updated with Decision(2012)7998 of 31/10/2012
17/07/2012 Centralised - Variation EMEA/H/C/2355/IB/3
Updated with Decision(2012)7998 of 31/10/2012
06/11/2012 Centralised - Variation (2012)7998 of 31/10/2012
16/08/2013 Centralised - Variation EMEA/H/C/2355/N/4
22/11/2013 Centralised - Variation EMEA/H/C/2355/IAIN/5/G
19/12/2013 Centralised - Variation EMEA/H/C/2355/IB/6
02/05/2014 Centralised - Variation EMEA/H/C/2355/IB/7