| Name |
Aciklovir Noridem 500 mg prašak za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-273345108 |
| Active Substance |
aciklovirnatrij |
| Composition |
svaka bočica sadrži 500 mg aciklovira (u obliku natrijeve soli) |
| Pharmaceutical Form |
prašak za otopinu za infuziju |
| Manufacturer |
Demo SA Pharmaceutical Industry, Krioneri Attiki, Grčka |
| Marketing Authorisation Holder |
Noridem Enterprises Limited, Evagorou and Makariou 1, Mitsi Bulding 3, Office 115, Nicosia, Cipar |
| Marketing Authorisation Date |
12.12.2022 |
| MA Period of Validity |
12.12.2027 |
| Classification Number |
UP/I-530-09/21-01/88 |
| Registration Number |
381-12-01/154-22-05 |
| 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 |
J05AB01 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
