Urifos 3 g granule za oralnu otopinu
Name | Urifos 3 g granule za oralnu otopinu |
---|---|
Marketing Authorisation Number | HR-H-755442271 |
Active Substance | fosfomicintrometamol |
Composition | jedna vrećica sadrži 3 g fosfomicina u obliku fosfomicintrometamola |
Pharmaceutical Form | granule za oralnu otopinu |
Packaging [MA Number for Packaging] | 1 vrećica s granulama, u kutiji [HR-H-755442271-01] 2 vrećice s granulama, u kutiji [HR-H-755442271-02] |
Manufacturer | Labiana Pharmaceuticals, S.L.U., Barcelona, Španjolska |
Marketing Authorisation Holder | PharmaS d.o.o., Radnička cesta 47, Zagreb, Hrvatska |
Marketing Authorisation Date | 12.01.2022 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/21-02/18 |
Registration Number | 381-12-01/70-22-10 |
Prescription | na recept |
Type of prescription | neponovljivi recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | J01XX01 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |