| Name |
Fragmin 2500 IU / 1 ml otopina za injekciju |
| Marketing Authorisation Number |
HR-H-444888961 |
| Active Substance |
dalteparinnatrij |
| Composition |
Jedan mililitar otopine sadrži 2 500 IU (anti-Xa) dalteparinnatrija
Jedna bočica s 4 ml otopine sadrži 10 000 IU (anti-Xa) dalteparinnatrija |
| Pharmaceutical Form |
otopina za injekciju |
| Manufacturer |
Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgija |
| Marketing Authorisation Holder |
Pfizer Croatia d.o.o., Slavonska avenija 6, Zagreb, Hrvatska |
| Marketing Authorisation Date |
23.08.2023 |
| MA Period of Validity |
23.08.2028 |
| Classification Number |
UP/I-530-09/22-01/02 |
| Registration Number |
381-12-01/171-23-14 |
| 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 |
B01AB04 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
