| Name |
Atosiban Alpha-Medical 6,75 mg/0,9 ml otopina za injekciju |
| Former Name |
Atosiban PharmIdea 6,75 mg/0,9 ml otopina za injekciju |
| Marketing Authorisation Number |
HR-H-756687130 |
| Active Substance |
atosibanacetat |
| Composition |
jedna bočica s 0,9 ml otopine sadrži 6,75 mg atosibana (u obliku atosibanacetata). |
| Pharmaceutical Form |
otopina za injekciju |
| Packaging [MA Number for Packaging] |
1 bočica s 0,9 ml otopine, u kutiji [HR-H-756687130-01]
|
| Manufacturer |
PharmIdea SIA, Olaine, Latvija |
| Marketing Authorisation Holder |
Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date |
01.02.2021 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/20-02/142 |
| Registration Number |
381-12-01/154-21-05 |
| Prescription |
na recept |
| Type of prescription |
ograničeni recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
G02CX01 |
| Medicinal product marketed in the Croatia |
Da |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
