Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Levetiracetam Hospira   
Auth. number : EU/1/13/889
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 Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Levetiracetam Hospira is indicated as adjunctive therapy
• in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years 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.
Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.
Marketing Authorisation Holder: Hospira UK Limited
Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

  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
10/01/2014 Centralised - Authorisation EMEA/H/C/2783 (2014)75 of 08/01/2014
05/03/2014 Centralised - Variation EMEA/H/C/2783/IB/1