| Name |
Antithrombin III Baxalta 50 IU/ml prašak i otapalo za otopinu za injekciju/infuziju |
| Former Name |
Antithrombin III Immuno 500 i.j.; Antithrombin III Baxter 500 IU prašak i otapalo za otopinu za infuziju; Antithrombin III Baxter 1000 IU prašak i otapalo za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-812546421 |
| Active Substance |
antitrombin III, ljudski |
| Composition |
jedna bočica s praškom za otopinu za injekciju/infuziju nominalno sadrži 500 IU ili 1000 IU antitrombina dobivenog iz ljudske plazme
1 ml otopine nakon rekonstitucije sadrži 50 IU ljudskog antitrombina III
|
| Pharmaceutical Form |
Prašak i otapalo za otopinu za injekciju / infuziju |
| Manufacturer |
Takeda Manufacturing Austria AG, Beč, Austrija |
| Marketing Authorisation Holder |
Baxalta Innovations GmbH, Industriestrasse 67, Beč, Austrija |
| Marketing Authorisation Date |
08.02.2019 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/15-02/297 |
| Registration Number |
381-12-01/38-19-37 |
| Prescription |
na recept |
| Type of prescription |
ograničeni recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
B01AB02 |
| Medicinal product marketed in the Croatia |
Da |
| SmPC |
download |
| PL |
download |
