Medicinal Products

Erlotinib Sandoz 100 mg filmom obložene tablete

Name Erlotinib Sandoz 100 mg filmom obložene tablete
Marketing Authorisation Number HR-H-127343397
Active Substance erlotinibum
Pharmaceutical Form filmom obložena tableta
Strength 100 mg
Packaging [MA Number for Packaging] 30 tableta u blisteru, u kutiji  [HR-H-127343397-01]
Manufacturer Lek Pharmaceuticals d.d., Ljubljana, Slovenija;
Remedica Ltd., Limassol, Cipar
Marketing Authorisation Holder Sandoz d.o.o., Maksimirska 120, Zagreb
Marketing Authorisation Date 27.06.2017
MA Period of Validity 27.06.2022
Classification Number UP/I-530-09/16-01/117
Registration Number 381-12-01/30-17-04
Composition svaka filmom obložena tableta sadrži 100 mg erlotiniba (u obliku erlotinibklorida)
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code L01XE03
Medicinal product marketed in the Croatia Ne
SmPC download
PL download
Public Assessment Report download
Educational materials
for healthcare professionals
Brošura za zdravstvene radnike, verzija 2
Back