Medicinal Products

Gefitinib Sandoz 250 mg filmom obložene tablete

Name Gefitinib Sandoz 250 mg filmom obložene tablete
Marketing Authorisation Number HR-H-844090380
Active Substance gefitinib
Composition svaka tableta sadrži 250 mg gefitiniba
Pharmaceutical Form filmom obložena tableta
Manufacturer Remedica Ltd., Limassol, Cipar
Lek Pharmaceuticals d.d., Ljubljana, Slovenija
Marketing Authorisation Holder Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska
Marketing Authorisation Date 25.01.2023
MA Period of Validity unlimited
Classification Number UP/I-530-09/22-02/152
Registration Number 381-12-01/154-23-03
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 Actual
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Public Assessment Report download

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