| Name |
Tigeciklin AptaPharma 50 mg prašak za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-729196778 |
| Active Substance |
tigeciklin |
| Composition |
jedna bočica sadrži 50 mg tigeciklina |
| Pharmaceutical Form |
prašak za otopinu za infuziju |
| Manufacturer |
Laboratorios Normon S.A., Tres Cantos – Madrid, Španjolska |
| Marketing Authorisation Holder |
Apta Medica Internacional d.o.o., Likozarjeva ulica 6, Ljubljana, Slovenija |
| Marketing Authorisation Date |
21.03.2024 |
| MA Period of Validity |
21.03.2029 |
| Classification Number |
UP/I-530-09/22-01/116 |
| Registration Number |
381-12-01/70-24-08 |
| 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 |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
