Monofer 100 mg/ml otopina za injekciju/infuziju
| Name | Monofer 100 mg/ml otopina za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-258767229 |
| Active Substance | željezova(III) derizomaltoza |
| Composition | jedan mililitar otopine sadrži 100 mg željeza u obliku željezove(III) derizomaltoze |
| Pharmaceutical Form | otopina za injekciju/infuziju |
| Manufacturer | Pharmacosmos A/S, Holbaek, Danska |
| Marketing Authorisation Holder | Pharmacosmos A/S, Roervangsvej 30, Holbaek, Danska |
| Marketing Authorisation Date | 27.07.2022 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/21-02/215 |
| Registration Number | 381-12-01/154-22-05 |
| 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 | B03AC |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 3 |
| Educational materials for patients / caregivers |
Brošura za bolesnike, verzija 3 |
