Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Levetiracetam SUN   
Auth. number : EU/1/11/741
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 SUN 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 SUN is indicated as adjunctive therapy
- in the treatment of partial onset seizures with or without secondary generalisation in adults,
adolescents and children from 4 years 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.
Levetiracetam SUN concentrate is an alternative for patients when oral administration is temporarily
not feasible.
Marketing Authorisation Holder: Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland
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
19/12/2011 Centralised - Authorisation EMEA/H/C/2051 (2011)9734 of 14/12/2011
13/07/2012 Centralised - Variation EMEA/H/C/2051/IB/1
Updated with Decision(2012)7986 of 31/10/2012
06/11/2012 Centralised - Variation (2012)7986 of 31/10/2012
16/01/2013 Centralised - Variation EMEA/H/C/2051/IA/2
Updated with Decision(2013)9731 of 18/12/2013
20/03/2013 Centralised - Notification EMEA/H/C/2051/N/3
Updated with Decision(2013)9731 of 18/12/2013
20/11/2013 Centralised - Variation EMEA/H/C/2051/IB/4
Updated with Decision(2013)9731 of 18/12/2013
23/12/2013 Centralised - Yearly update (2013)9731 of 18/12/2013
14/02/2014 Centralised - Variation EMEA/H/C/2051/IB/6
Updated with Decision(2015)743 of 06/02/2015
28/03/2014 Centralised - Variation EMEA/H/C/2051/IB/7
Updated with Decision(2015)743 of 06/02/2015
10/02/2015 Centralised - Yearly update (2015)743 of 06/02/2015