| Name |
Kabozantinib Teva 60 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-315112621 |
| Active Substance |
kabozantinib (S)-malat |
| Composition |
jedna filmom obložena tableta sadrži 76,02 mg kabozantinib (S)-malata u količini koja odgovara 60 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-530-09/23-01/74 |
| 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 |
| Public Assessment Report |
download
|
