Fokleros 150 mg filmom obložene tablete
Name | Fokleros 150 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-747716354 |
Active Substance | erlotinibklorid |
Composition | jedna filmom obložena tableta sadrži 150 mg erlotiniba u obliku erlotinibklorida |
Pharmaceutical Form | Filmom obložena tableta |
Manufacturer | Alkaloid - INT d.o.o., Ljubljana - Črnuče, Slovenija |
Marketing Authorisation Holder | Alkaloid - INT d.o.o., Šlandrova ulica 4, Ljubljana - Črnuče, Slovenija |
Marketing Authorisation Date | 13.12.2022 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/22-02/138 |
Registration Number | 381-12-01/154-22-02 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L01EB02 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |