Name |
Tramadol Krka 50 mg otopina za injekciju/infuziju |
Former Name |
Tramadol Farmal 50 mg/ml otopina za injekcije |
Marketing Authorisation Number |
HR-H-883684879 |
Active Substance |
tramadolklorid |
Composition |
1 ml otopine za injekciju/infuziju (1 ampula) sadrži 50 mg tramadolklorida |
Pharmaceutical Form |
Otopina za injekciju / infuziju |
Manufacturer |
Krka d.d., Novo mesto, Novo Mesto, Slovenija |
Marketing Authorisation Holder |
Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
Marketing Authorisation Date |
29.06.2018 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/17-02/16 |
Registration Number |
381-12-01/70-18-02 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
N02AX02 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |