en

PRODUCT DETAIL

Fluconazole Noridem 2 mg/ml infúzny roztok

Code 1156F
MA number 26/0292/25-S
Product Form: sol inf 20x200 ml/400 mg (fľ. PP s lisovaným plast. uzáverom s gumovým tesnením a sťahovacím krúžkom)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Mutual recognition procedure
MAH, country: Noridem Enterprises Ltd., Cyprus
Therapeutic Class: 26 - ANTIMYCOTICA (LOKÁLNE A CELKOVÉ)
ATC:
J ANTIINFECTIVES FOR SYSTEMIC USE
J02 ANTIMYCOTICS FOR SYSTEMIC USE
J02A ANTIMYCOTICS FOR SYSTEMIC USE
J02AC Triazole and tetrazole derivatives
J02AC01 Fluconazole
Shelf life: 24
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 23.09.2025
Validity: 23.09.2030
Pediatric indication: Yes
Pediatric posology: Yes
SPC: SPC_Fluconazole Noridem 2 mg_ml infúzny roztok_09_2025.pdf  
PIL: PIL_Fluconazole Noridem 2 mg_ml infúzny roztok_09_2025.pdf  
Safety feature Yes
Data update: 25.09.2025
eu-flag.png sk-flag.png