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- Levetiracetam Actavis
Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Levetiracetam Actavis
|
| Auth. number : | EU/1/11/713 |
| INN : | levetiracetam |
| ATC: | N - Nervous system N03 - Antiepileptics N03A - Antiepileptics N03AX - Other antiepileptics 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| 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 |