Xabogard 50 mg/ml disperzija za injekciju/infuziju
Name | Xabogard 50 mg/ml disperzija za injekciju/infuziju |
---|---|
Former Name | Xabogard 50 mg/ml otopina za injekciju/infuziju |
Marketing Authorisation Number | HR-H-025204700 |
Active Substance | željezova karboksimaltoza |
Composition | jedan ml disperzije sadrži 50 mg željeza u obliku željezove karboksimaltoze |
Pharmaceutical Form | Disperzija za injekciju/infuziju |
Packaging [MA Number for Packaging] | 1 bočica s 2 ml disperzije, u kutiji [HR-H-025204700-01] 2 bočice s 2 ml disperzije, u kutiji [HR-H-025204700-02] 5 bočica s 2 ml disperzije, u kutiji [HR-H-025204700-03] 1 bočica s 10 ml disperzije, u kutiji [HR-H-025204700-04] 2 bočice s 10 ml disperzije, u kutiji [HR-H-025204700-05] 5 bočica s 10 ml disperzije, u kutiji [HR-H-025204700-06] 1 bočica s 20 ml disperzije, u kutiji [HR-H-025204700-07] |
Manufacturer | Lek Pharmaceuticals d.d., Ljubljana, Slovenija |
Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
Marketing Authorisation Date | 13.12.2022 |
MA Period of Validity | 13.12.2027 |
Classification Number | UP/I-530-09/20-01/325 |
Registration Number | 381-12-01/154-22-12 |
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 |