Medicinal Products

Vorikonazol Sandoz 200 mg prašak za otopinu za infuziju

Name Vorikonazol Sandoz 200 mg prašak za otopinu za infuziju
Marketing Authorisation Number HR-H-519187061
Active Substance voriconazolum
Pharmaceutical Form prašak za otopinu za infuziju
Strength 200 mg
Packaging [MA Number for Packaging] 1 bočica s praškom, u kutiji  [HR-H-519187061-01]
5 bočica s praškom, u kutiji  [HR-H-519187061-02]
10 bočica s praškom, u kutiji  [HR-H-519187061-03]
Manufacturer Lek Pharmaceuticals d.d., Ljubljana, Slovenija
Salutas Pharma GmbH, Barleben, Njemačka
Marketing Authorisation Holder Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska
Marketing Authorisation Date 29.11.2018
MA Period of Validity unlimited
Classification Number UP/I-530-09/18-02/108
Registration Number 381-12-01/38-18-03
Composition jedna bočica sadrži 200 mg vorikonazola
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code J02AC03
Medicinal product marketed in the Croatia Da
SmPC download
PL download
Public Assessment Report download
Educational materials
for healthcare professionals
Brošura s pitanjima i odgovorima za zdravstvene radnike, ver 2
Popis za provjeru za zdravstvene djelatnike, ver 2
Educational materials
for patients / caregivers
Kartica za bolesnika, ver 2
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