| Name |
Atosiban Makpharm 37,5 mg/5 ml koncentrat za otopinu za infuziju |
| Former Name |
Atosiban PharmIdea 37,5 mg/5 ml koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-596925089 |
| Active Substance |
atosibanacetat |
| Composition |
jedna bočica s 5 ml otopine sadrži 37,5 mg atosibana (u obliku atosibanacetata) |
| Pharmaceutical Form |
koncentrat za otopinu za infuziju |
| Packaging [MA Number for Packaging] |
1 bočica s 5 ml otopine, u kutiji [HR-H-596925089-01]
|
| Manufacturer |
PharmIdea SIA, Olaine, Latvija |
| Marketing Authorisation Holder |
Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, Hrvatska |
| Marketing Authorisation Date |
24.04.2024 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/20-02/143 |
| Registration Number |
381-12-01/70-24-09 |
| 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 |
