Medicinal Products

Voramol 50 mg filmom obložene tablete

Name Voramol 50 mg filmom obložene tablete
Marketing Authorisation Number HR-H-265948982
Active Substance voriconazolum
Pharmaceutical Form filmom obložena tableta
Strength 50 mg
Packaging [MA Number for Packaging] 2 tablete u blisteru, u kutiji  [HR-H-265948982-01]
10 tableta u blisteru, u kutiji  [HR-H-265948982-02]
14 tableta u blisteru, u kutiji  [HR-H-265948982-03]
20 tableta u blisteru, u kutiji  [HR-H-265948982-04]
28 tableta u blisteru, u kutiji  [HR-H-265948982-05]
30 tableta u blisteru, u kutiji  [HR-H-265948982-06]
50 tableta u blisteru, u kutiji  [HR-H-265948982-07]
56 tableta u blisteru, u kutiji  [HR-H-265948982-08]
100 tableta u blisteru, u kutiji  [HR-H-265948982-09]
30 tableta u bočici, u kutiji  [HR-H-265948982-10]
Manufacturer Pharmathen S.A., Pallini Attiki, Grčka
Pharmathen International S.A., Rodopi, Grčka
Marketing Authorisation Holder Alvogen IPCo S.ar.l., 5, Rue Heienhaff, Senningerberg, Luksemburg
Marketing Authorisation Date 29.05.2015
MA Period of Validity 29.05.2020
MA Revocation Date 16.01.2020*
Classification Number UP/I-530-09/14-01/65
Registration Number 381-12-01/14-15-03
Composition svaka tableta sadrži 50 mg vorikonazola
Prescription na recept
Type of prescription neponovljivi recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code J02AC03
Medicinal product marketed in the Croatia Trajni prekid opskrbe
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

*Note

Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.

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