| Name |
Vankomicin AptaPharma 500 mg prašak za koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-503941848 |
| Active Substance |
vankomicinklorid |
| Composition |
jedna bočica sadrži 500 mg vankomicinklorida što odgovara 500 000 IU vankomicina |
| Pharmaceutical Form |
Prašak za koncentrat za otopinu za infuziju |
| Manufacturer |
Laboratorio Reig Jofre S.A., Sant Joan Despí (Barcelona), Španjolska |
| Marketing Authorisation Holder |
Apta Medica Internacional d.o.o., Likozarjeva ulica 6, Ljubljana, Slovenija |
| Marketing Authorisation Date |
01.04.2026 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/25-02/195 |
| Registration Number |
381-12-01/171-26-05 |
| 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 |
J01XA01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
