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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Invented name:||Levetiracetam Actavis Group|
|Auth. number :||EU/1/11/738|
|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
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.
|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|