Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium
Keppra 500 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Yellow, 16 mm oblong, scored and debossed with the code “ucb” and “500” on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. |
Each film-coated tablet contains 500 mg levetiracetam.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Levetiracetam |
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 |
|---|
|
Tablet core: Croscarmellose sodium Film-coating: Polyvinyl alcohol-part. hydrolyzed |
Aluminium/PVC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 film- coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets.
Aluminium/PVC perforated unit dose blisters placed into cardboard boxes containing 100 × 1 film- coated tablet.
Not all pack sizes may be marketed.
UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium
EU/1/00/146/006
EU/1/00/146/007
EU/1/00/146/008
EU/1/00/146/009
EU/1/00/146/010
EU/1/00/146/011
EU/1/00/146/012
EU/1/00/146/013
EU/1/00/146/035
Date of first authorisation: 29 September 2000
Date of latest renewal: 20 August 2015
| 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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