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 |
Packaging [MA Number for Packaging] |
1 bočica s praškom, u kutiji [HR-H-492814061-01]
|
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 |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
L01XG01 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|