| Name |
Bortezomib Actavis 3,5 mg prašak za otopinu za injekciju |
| Marketing Authorisation Number |
HR-H-492814061 |
| Active Substance |
bortezomib |
| Composition |
jedna bočica sadrži 3,5 mg bortezomiba (u obliku estera boronatne kiseline i manitola) |
| Pharmaceutical Form |
prašak za otopinu za injekciju |
| Manufacturer |
S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska |
| Marketing Authorisation Holder |
Actavis Group PTC ehf., Dalshraun 1, Hafnarfjoerdur, Island |
| Marketing Authorisation Date |
16.07.2020 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/19-02/180 |
| Registration Number |
381-12-01/38-20-03 |
| 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 |
L01XG01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
