- Current languageen
Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Invented name:||Levetiracetam Hospira|
|Auth. number :||EU/1/13/889|
|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
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.
|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|