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Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Levetiracetam Actavis Group   
Auth. number : EU/1/11/738
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 Group 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.
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
07/12/2011 Centralised - Authorisation EMEA/H/C/2305 (2011)9173 of 05/12/2011
13/09/2012 Centralised - Variation EMEA/H/C/2305/IB/1
Updated with Decision(2012)7898 of 29/10/2012
01/11/2012 Centralised - Variation (2012)7898 of 29/10/2012
25/09/2013 Centralised - Variation EMEA/H/C/2305/N/2
19/12/2013 Centralised - Variation EMEA/H/C/2305/IB/3
25/04/2014 Centralised - Variation EMEA/H/C/2305/IB/4