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 |