| Name |
Plivatinib 100 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-546437338 |
| Active Substance |
imatinibmesilat |
| Composition |
svaka filmom obložena tableta od 100 mg sadrži 100 mg imatiniba (u obliku imatinibmesilata) |
| Pharmaceutical Form |
filmom obložena tableta |
| Manufacturer |
Pliva Hrvatska d.o.o., Zagreb, Hrvatska |
| Marketing Authorisation Holder |
Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date |
24.10.2016 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/15-02/491 |
| Registration Number |
381-12-01/38-16-04 |
| 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 |
L01EA01 |
| Marketing status |
stavljeno u promet |
| Shortage status |
u tijeku |
| SmPC |
download |
| PL |
download |