Navigation path

Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Levetiracetam ratiopharm   
Auth. number : EU/1/11/702
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: Levetiracetam ratiopharm is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Levetiracetam ratiopharm is indicated as adjunctive therapy
• in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, 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: ratiopharm GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland
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
31/08/2011 Centralised - Authorisation EMEA/H/C/2244 (2011)6239 of 26/08/2011
02/02/2012 Centralised - Variation EMEA/H/C/2244/IB/4
Updated with Decision(2012)6389 of 10/09/2012
10/08/2012 Centralised - Variation EMEA/H/C/2244/IB/5
Updated with Decision(2012)6389 of 10/09/2012
12/09/2012 Centralised - Variation (2012)6389 of 10/09/2012
10/12/2013 Centralised - Variation EMEA/H/C/2244/IB/8
Updated with Decision(2014)9824 of 11/12/2014
24/04/2014 Centralised - Variation EMEA/H/C/2244/IB/9
Updated with Decision(2014)9824 of 11/12/2014
15/12/2014 Centralised - Yearly update (2014)9824 of 11/12/2014