| Name |
Tramadol Krka 100 mg otopina za injekciju/infuziju |
| Former Name |
Tramadol Farmal 100 mg/2 ml otopina za injekcije |
| Marketing Authorisation Number |
HR-H-380362751 |
| Active Substance |
tramadolklorid |
| Composition |
2 ml otopine za injekciju/infuziju (1 ampula) sadrži 100 mg tramadolklorida
1 ml otopine za injekciju/infuziju 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-530-09/17-02/13 |
| Registration Number |
381-12-01/70-18-03 |
| 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 |
N02AX02 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |