KEPPRA Oral solution Ref.[116930] Active ingredients: Levetiracetam

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium

Product name and form

Keppra 100 mg/ml oral solution.

Pharmaceutical Form

Oral solution.

Clear liquid.

Qualitative and quantitative composition

Each ml contains 100 mg levetiracetam

Excipients with known effect: Each ml contains 2.7 mg of methyl parahydroxybenzoate (E218), 0.3 mg of propyl parahydroxybenzoate (E216) and 300 mg of maltitol liquid.

For the full list of excipients, see section 6.1.

Active Ingredient

Levetiracetam, is a pyrrolidone derivative, chemically unrelated to existing antiepileptic active substances. Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect. The primary metabolite is inactive.

List of Excipients

Sodium citrate
Citric acid monohydrate
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Ammonium glycyrrhizate
Glycerol (E422)
Maltitol liquid (E965)
Acesulfame potassium (E950)
Grape flavour
Purified water

Pack sizes and marketing

300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 10 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).

150 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 5 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).

150 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 1 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).

Marketing authorization holder

UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium

Marketing authorization dates and numbers

EU/1/00/146/027
EU/1/00/146/031
EU/1/00/146/032

Date of first authorisation: 29 September 2000
Date of latest renewal: 20 August 2015

Drugs

Drug Countries
KEPPRA Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, Netherlands, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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