Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Levetiracetam Teva   
Auth. number : EU/1/11/701
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: 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: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, 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
31/08/2011 Centralised - Authorisation EMEA/H/C/2316 (2011)6240 of 26/08/2011
19/12/2011 Centralised - Variation EMEA/H/C/2316/IB/1/G
Updated with Decision(2012)4067 of 11/06/2012
02/02/2012 Centralised - Variation EMEA/H/C/2316/IA/2
Updated with Decision(2012)4067 of 11/06/2012
16/03/2012 Centralised - Variation EMEA/H/C/2316/IB/3
Updated with Decision(2012)4067 of 11/06/2012
13/06/2012 Centralised - Variation (2012)4067 of 11/06/2012
13/07/2012 Centralised - Variation EMEA/H/C/2316/IB/1
Updated with Decision(2012)7987 of 31/10/2012
23/08/2012 Centralised - Variation EMEA/H/C/2316/IA/7
Updated with Decision(2012)7987 of 31/10/2012
06/11/2012 Centralised - Variation (2012)7987 of 31/10/2012
03/01/2014 Centralised - Variation EMEA/H/C/2316/IB/10
28/03/2014 Centralised - Variation EMEA/H/C/2316/IB/11
01/07/2014 Centralised - Variation EMEA/H/C/2316/IB/12