Name |
Karmustin Teva 100 mg prašak i otapalo za koncentrat za otopinu za infuziju |
Marketing Authorisation Number |
HR-H-333238133 |
Active Substance |
karmustin |
Composition |
jedna bočica praška sadrži 100 mg karmustina |
Pharmaceutical Form |
Prašak i otapalo za koncentrat za otopinu za infuziju |
Manufacturer |
S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska |
Marketing Authorisation Holder |
Teva B.V., Swensweg 5, Haarlem, Nizozemska |
Marketing Authorisation Date |
03.02.2021 |
MA Period of Validity |
03.02.2026 |
Classification Number |
UP/I-530-09/19-01/249 |
Registration Number |
381-12-01/154-21-04 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
L01AD01 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |