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 | Remedica Ltd., Limassol, Cipar Lek Pharmaceuticals d.d., Ljubljana, Slovenija |
Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
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 |