Name |
Ganireliks Theramex 0,25 mg/0,5 ml otopina za injekciju u napunjenoj štrcaljki |
Marketing Authorisation Number |
HR-H-875804662 |
Active Substance |
ganireliksacetat |
Composition |
jedna napunjena štrcaljka sadrži 0,25 mg ganireliksa (u obliku ganireliksacetata) u 0,5 ml vodene otopine |
Pharmaceutical Form |
Otopina za injekciju u napunjenoj štrcaljki |
Manufacturer |
Gp-Pharm S.A., Sant Quinti de Mediona, Barcelona, Španjolska |
Marketing Authorisation Holder |
Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin, Irska |
Marketing Authorisation Date |
18.08.2023 |
MA Period of Validity |
18.08.2028 |
Classification Number |
UP/I-530-09/22-01/37 |
Registration Number |
381-12-01/171-23-09 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
H01CC01 |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|