| Name |
Levetiracetam Kalceks 100 mg/ml koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-511809495 |
| Active Substance |
levetiracetam |
| Composition |
jedan ml otopine sadrži 100 mg levetiracetama |
| Pharmaceutical Form |
Koncentrat za otopinu za infuziju |
| Manufacturer |
AS Kalceks, Riga, Latvija |
| Marketing Authorisation Holder |
AS Kalceks, Krustpils iela 71E, Riga, Latvija |
| Marketing Authorisation Date |
13.01.2026 |
| MA Period of Validity |
13.01.2031 |
| Classification Number |
UP/I-530-09/25-01/34 |
| Registration Number |
381-12-01/286-26-09 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
N03AX14 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
