Medicinal Products

Gefitinib Pliva 250 mg filmom obložene tablete

Name Gefitinib Pliva 250 mg filmom obložene tablete
Marketing Authorisation Number HR-H-317459732
Active Substance gefitinib
Composition jedna filmom obložena tableta sadrži 250 mg gefitiniba
Pharmaceutical Form filmom obložena tableta
Manufacturer Teva Pharma S.L.U., Zaragoza, Španjolska
Merckle GmbH, Blaubeuren, Njemačka
Pliva Hrvatska d.o.o., Zagreb, Hrvatska
Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska
Marketing Authorisation Holder Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska
Marketing Authorisation Date 17.08.2023
MA Period of Validity unlimited
Classification Number UP/I-530-09/23-02/01
Registration Number 381-12-01/286-23-04
Prescription Medicinal product subject to medical prescription
Type of prescription Medicinal product subject to restricted medical prescription
Distribution Supply through pharmacies (community)
Advertising to general public not allowed
ATC Code L01EB01
Marketing status Marketed
Shortage status No shortage
SmPC download
PL download
Public Assessment Report download

Packaging

Back