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 |
| Packaging [MA Number for Packaging] | 5 ampula s 1 ml otopine, u kutiji [HR-H-258767229-01] 10 ampula s 1 ml otopine, u kutiji [HR-H-258767229-02] 5 ampula s 2 ml otopine, u kutiji [HR-H-258767229-03] 10 ampula s 2 ml otopine, u kutiji [HR-H-258767229-04] 2 ampule s 5 ml otopine, u kutiji [HR-H-258767229-05] 5 ampula s 5 ml otopine, u kutiji [HR-H-258767229-06] 2 ampule s 10 ml otopine, u kutiji [HR-H-258767229-07] 5 ampula s 10 ml otopine, u kutiji [HR-H-258767229-08] 1 bočica s 1 ml otopine, u kutiji [HR-H-258767229-09] 5 bočica s 1 ml otopine, u kutiji [HR-H-258767229-10] 10 bočica s 1 ml otopine, u kutiji [HR-H-258767229-11] 5 bočica s 2 ml otopine, u kutiji [HR-H-258767229-12] 10 bočica s 2 ml otopine, u kutiji [HR-H-258767229-13] 1 bočica s 5 ml otopine, u kutiji [HR-H-258767229-14] 2 bočice s 5 ml otopine, u kutiji [HR-H-258767229-15] 5 bočica s 5 ml otopine, u kutiji [HR-H-258767229-16] 1 bočica s 10 ml otopine, u kutiji [HR-H-258767229-17] 2 bočice s 10 ml otopine, u kutiji [HR-H-258767229-18] 5 bočica s 10 ml otopine, u kutiji [HR-H-258767229-19] |
| 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 | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | B03AC |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 2 |
| Educational materials for patients / caregivers |
Brošura za bolesnike, verzija 2 |
