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- Levetiracetam Actavis Group
Community Register of medicinal products
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: | N - Nervous system N03 - Antiepileptics N03A - Antiepileptics N03AX - Other antiepileptics 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
|
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 |
| 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 |