| Name |
Tigeciklin Galenika 50 mg prašak za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-655214807 |
| Active Substance |
tigeciklin |
| Composition |
jedna bočica sadrži 50 mg tigeciklina |
| Pharmaceutical Form |
prašak za otopinu za infuziju |
| Manufacturer |
Sofarimex Indústria Quimica e Farmacêutica S.A., Cacém, Portugal |
| Marketing Authorisation Holder |
Galenika International Kft., Baross utca 165/3, Budaörs, Mađarska |
| Marketing Authorisation Date |
06.06.2025 |
| MA Period of Validity |
06.06.2030 |
| Classification Number |
UP/I-530-09/23-01/325 |
| Registration Number |
381-12-01/70-25-09 |
| 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 |
J01AA12 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Summary of risk management plan |
download |
