Name |
Vankomicin AptaPharma 1000 mg prašak za koncentrat za otopinu za infuziju |
Marketing Authorisation Number |
HR-H-541482958 |
Active Substance |
vankomicinklorid |
Composition |
jedna bočica sadrži 1000 mg vankomicinklorida što odgovara 1 000 000 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 |
10.08.2021 |
MA Period of Validity |
10.08.2026 |
Classification Number |
UP/I-530-09/19-01/295 |
Registration Number |
381-12-01/70-21-02 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
J01XA01 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|