| 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 |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
H01CC01 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
