Medicinal Products

Keppra

The medicinal product has been authorised by the European Commission (EC) via centralised procedure in all EU Member States, based on the European Medicines Agency (EMA) experts' opinion.

Name Keppra
Active Substance levetiracetam
Prescription Medicinal product subject to medical prescription
Type of prescription Medicinal product on medical prescription for renewable delivery (filmom obložena tableta, oralna otopina)
Medicinal product subject to restricted medical prescription (koncentrat za otopinu za infuziju)
Distribution Supply through pharmacies (community)
ATC Code N03AX14
Marketing status Marketed
Shortage status No shortage
Summary of product characteristics (SmPC), labelling and package leaflet (PL) download
Link to the European Medicines Agency's (EMA) product information download
Link to the European Commission's (EC) decisions download

Packaging

Direct Healthcare Professional Communication

Name Date Download
Pismo zdravstvenim radnicima o riziku od medikacijskih pogrešaka povezanih s predoziranjem lijekovima koji sadrže levetiracetam u obliku oralne otopine (Keppra 100 mg/ml oralna otopina) 03.01.2017 Medis Adria d.o.o.
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