Kalcijev folinat Sandoz 10 mg/ml otopina za injekciju/infuziju
Name | Kalcijev folinat Sandoz 10 mg/ml otopina za injekciju/infuziju |
---|---|
Former Name | Calciumfolinat Ebewe 10 mg/ml otopina za injekciju ili infuziju |
Marketing Authorisation Number | HR-H-798045388 |
Active Substance | kalcijev folinat hidrat |
Composition | jedan ml otopine za injekciju/infuziju sadrži 10 mg folinatne kiseline u obliku kalcijevog folinat hidrata |
Pharmaceutical Form | otopina za injekciju/infuziju |
Manufacturer | Ebewe Pharma GmbH Nfg. KG, Unterach am Attersee, Austrija
Sandoz GmbH, Kundl, Austrija Salutas Pharma GmbH, Barleben, Njemačka |
Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
Marketing Authorisation Date | 07.03.2022 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/21-02/16 |
Registration Number | 381-12-01/70-22-04 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | V03AF03 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |