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PRODUCT DETAIL

SPORANOX

Code 14924
MA number 26/0194/90-CS
Product Form: cps dur 28x100 mg (blis.PVC/LDPE/PVDC/Al)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
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
J02AC02 Itraconazole
Shelf life: 36
Container: blister PVC/LDPE/PVDC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 18.06.1990
Pediatric warnings: Yes
PIL: PIL_Sporanox cps dur_10.2023.pdf  
SPC: SPC_Sporanox cps dur_10.2023.pdf  
Safety feature Yes
Data update: 22.03.2023
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