Name |
Kabozantinib Teva 40 mg filmom obložene tablete |
Marketing Authorisation Number |
HR-H-146288076 |
Active Substance |
kabozantinib (S)-malat |
Composition |
jedna filmom obložena tableta sadrži 50,68 mg kabozantinib (S)-malata u količini koja odgovara 40 mg kabozantiniba |
Pharmaceutical Form |
Filmom obložena tableta |
Manufacturer |
Pliva Hrvatska d.o.o., Zagreb, Hrvatska |
Marketing Authorisation Holder |
Teva B.V., Swensweg 5, Haarlem, Nizozemska |
Marketing Authorisation Date |
09.06.2025 |
MA Period of Validity |
09.06.2030 |
Classification Number |
UP/I-530-09/23-01/73 |
Registration Number |
381-12-01/171-25-08 |
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 |
L01EX07 |
Marketing status |
nije stavljeno u promet |
SmPC |
download |
PL |
download |