Name |
Erlotinib Viatris 150 mg filmom obložene tablete |
Former Name |
Erlotinib Mylan 150 mg filmom obložene tablete |
Marketing Authorisation Number |
HR-H-088638189 |
Active Substance |
erlotinibklorid |
Composition |
jedna filmom obložena tableta sadrži 150 mg erlotiniba (u obliku erlotinibklorida) |
Pharmaceutical Form |
filmom obložena tableta |
Manufacturer |
Remedica Ltd., Limassol, Cipar |
Marketing Authorisation Holder |
Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
Marketing Authorisation Date |
22.03.2024 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/21-02/127 |
Registration Number |
381-12-01/171-24-31 |
Prescription |
Medicinal product subject to medical prescription |
Type of prescription |
ograničeni recept
|
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
not allowed |
ATC Code |
L01EB02 |
Marketing status |
privremeni prekid opskrbe |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|