Levetiracetam Sun
Authorised
This medicine is authorised for use in the European Union
levetiracetam
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Levetiracetam Sun. 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 Sun.
Levetiracetam Sun is an epilepsy medicine. It 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 Sun 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 four years 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).
Levetiracetam Sun is used as an alternative for patients when oral treatment is temporarily not feasible.
Levetiracetam Sun contains the active substance levetiracetam and is a ‘generic medicine’. This means that Levetiracetam Sun contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Keppra.
Levetiracetam Sun is given by infusion (drip into a vein) and it can only be obtained with a prescription.
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. For patients aged between 4 years and 17 years weighing less than 50 kg, the dose depends on body weight.
The use of Levetiracetam Sun infusion should be temporary.
For more information about using Levetiracetam Sun, see the package leaflet or contact your doctor or pharmacist.
The active substance in Levetiracetam Sun, levetiracetam, is an epilepsy medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact way in which levetiracetam works is still unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells. This helps Levetiracetam Sun to stabilise electrical activity in the brain and prevent seizures.
The company provided data from the published literature on levetiracetam. Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Keppra, and do not need to be repeated for Levetiracetam Sun.
As for every medicine, the company provided data on the quality of Levetiracetam Sun. There was no need for ‘bioequivalence’ studies to investigate whether Levetiracetam Sun is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Levetiracetam Sun is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Because Levetiracetam Sun is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The European Medicines Agency concluded that, in accordance with EU requirements, Levetiracetam Sun has been shown to be comparable to Keppra. Therefore, the Agency’s view was that, as for Keppra, the benefits of Levetiracetam Sun outweigh the identified risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Levetiracetam Sun have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Levetiracetam Sun are continuously monitored. Suspected side effects reported with Levetiracetam Sun are carefully evaluated and any necessary action taken to protect patients.
Levetiracetam Sun received a marketing authorisation valid throughout the EU on 14 December 2011.
Product information
Latest procedure affecting product information:
VR/0000265264
02/05/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Levetiracetam Sun
- Active substance
- levetiracetam
- International non-proprietary name (INN) or common name
- levetiracetam
- Therapeutic area (MeSH)
- Epilepsy
- Anatomical therapeutic chemical (ATC) code
- N03AX14
Pharmacotherapeutic group
Other antiepilepticsTherapeutic indication
Levetiracetam Sun 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 Sun is indicated as adjunctive therapy:
- in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four 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 Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.
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