| Name |
Norditropin FlexPro 10 mg/1,5 ml otopina za injekciju u napunjenoj brizgalici |
| Marketing Authorisation Number |
HR-H-992228126 |
| Active Substance |
somatropin |
| Composition |
1 ml otopine sadrži 6,7 mg somatropina; 1 napunjena brizgalica (1,5 ml) sadrži 10 mg somatropina |
| Pharmaceutical Form |
Otopina za injekciju u napunjenoj brizgalici |
| Manufacturer |
Novo Nordisk A/S, Bagsvaerd, Danska |
| Marketing Authorisation Holder |
Novo Nordisk A/S, Novo Alle 1, Bagsvaerd, Danska |
| Marketing Authorisation Date |
29.04.2025 |
| MA Period of Validity |
29.04.2030 |
| Classification Number |
UP/I-530-09/24-01/428 |
| Registration Number |
381-12-01/70-25-06 |
| 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 |
H01AC01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
