| 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 |
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 |
L01EB02 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
