Levetiracetam Actavis Group

levetiracetam

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This is a summary of the European public assessment report (EPAR) for Levetiracetam Actavis Group. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levetiracetam Actavis Group.

What is Levetiracetam Actavis Group?

Levetiracetam Actavis Group is a medicine that contains the active substance levetiracetam. It is available as an oral solution (100 mg/ml).

Levetiracetam Actavis Group is a ‘generic medicine’. This means that Levetiracetam Actavis Group is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Keppra.

What is Levetiracetam Actavis Group used for?

Levetiracetam Actavis Group can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain.

Levetiracetam Actavis Group can also be used as an add-on to other anti-epileptic medicines to treat:

  • partial-onset seizures with or without generalisation in patients from one month of age;
  • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
  • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

The medicine can only be obtained with a prescription. 

How is Levetiracetam Actavis Group used?

When Levetiracetam Actavis Group is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day. The dose can be further increased at two-week intervals according to the patient’s response, to a maximum dose of 1,500 mg twice a day.

When Levetiracetam Actavis Group is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1,500 mg twice a day. In patients aged between six months and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day. In babies aged between one and six months, the starting dose is 7 mg/kg twice a day, using the oral solution. This can be increased up to 21 mg/kg twice a day.

Lower doses are used in patients who have problems with their kidneys (such as older patients).

The oral solution may be mixed in a glass of water before it is taken.

How does Levetiracetam Actavis Group work?

The active substance in Levetiracetam Actavis Group, levetiracetam, is an anti-epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells. This helps levetiracetam to stabilise electrical activity in the brain and prevent seizures.

How has Levetiracetam Actavis Group been studied?

Because Levetiracetam Actavis Group is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What benefit has Levetiracetam Actavis Group shown during the studies?

Because Levetiracetam Actavis Group is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

What is the risk associated with Levetiracetam Actavis Group?

The most common side effects with Levetiracetam Actavis Group (seen in more than 1 patient in 10) are somnolence (sleepiness), and asthenia (weakness) or fatigue (tiredness). For the full list of all side effects reported with Levetiracetam Actavis Group, see the package leaflet.

Levetiracetam Actavis Group must not be used in people who are hypersensitive (allergic) to levetiracetam, to other pyrrolidone derivatives (medicines with a similar structure to levetiracetam), or to any of the other ingredients.

Why has Levetiracetam Actavis Group been approved?

The CHMP concluded that, in accordance with EU requirements, Levetiracetam Actavis Group has been shown to have comparable quality and to be bioequivalent to Keppra. Therefore, the CHMP’s view was that, as for Keppra, the benefit outweighs the identified risk. The Committee recommended that Levetiracetam Actavis Group be given marketing authorisation.

Other information about Levetiracetam Actavis Group

The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Actavis Group on 5 December 2011.

For more information about treatment with Levetiracetam Actavis Group, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Levetiracetam Actavis Group : EPAR - Summary for the public BG = bălgarski 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public ES = español 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public CS = čeština 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public DA = dansk 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public DE = Deutsch 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public ET = eesti keel 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public EL = elliniká 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public EN = English 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public FR = français 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public IT = italiano 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public LV = latviešu valoda 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public LT = lietuvių kalba 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public HU = magyar 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public MT = Malti 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public NL = Nederlands 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public PL = polski 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public PT = português 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public RO = română 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public SK = slovenčina 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public SL = slovenščina 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public FI = suomi 14/12/2011  
Levetiracetam Actavis Group : EPAR - Summary for the public SV = svenska 14/12/2011  

This EPAR was last updated on 10/06/2016 .

Authorisation details

Product details

Product details for Levetiracetam Actavis Group
NameLevetiracetam Actavis Group
Agency product numberEMEA/H/C/002305
Active substance

levetiracetam

International non-proprietary name (INN) or common name

levetiracetam

Therapeutic area Epilepsy
Anatomical therapeutic chemical (ATC) code N03AX14
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Levetiracetam Actavis Group
Marketing-authorisation holder

Actavis Group PTC ehf

Revision7
Date of issue of marketing authorisation valid throughout the European Union05/12/2011

Contact address:

Actavis Group PTC ehf
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland

Product information

Product information

08/03/2016  Levetiracetam Actavis Group -EMEA/H/C/002305 -IB/0011

Name Language First published Last updated
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016
Levetiracetam Actavis Group : EPAR - Product Information SV = svenska 14/12/2011 10/06/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  
Levetiracetam Actavis Group : EPAR - All Authorised presentations SV = svenska 14/12/2011  

Pharmacotherapeutic group

Antiepileptics

Therapeutic 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.

Levetiracetam Actavis Group 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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Levetiracetam Actavis Group : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 12/09/2012 10/06/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Levetiracetam Actavis Group : EPAR - Public assessment report SV = svenska 14/12/2011  
CHMP summary of positive opinion for Levetiracetam Actavis Group SV = svenska 23/09/2011  

Authorised

This medicine is approved for use in the European Union

More information on Levetiracetam Actavis Group