Psotriol 50 mikrograma/g + 0,5 mg/g gel
Name | Psotriol 50 mikrograma/g + 0,5 mg/g gel |
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Marketing Authorisation Number | HR-H-443641742 |
Active Substance | kalcipotriol hidrat betametazondipropionat |
Composition | jedan gram gela sadrži 50 mikrograma kalcipotriola (u obliku hidrata) i 0,5 mg betametazona (u obliku dipropionata) |
Pharmaceutical Form | gel |
Manufacturer | mibe GmbH Arzneimittel, Brehna, Njemačka |
Marketing Authorisation Holder | Mibe Pharmaceuticals d.o.o., Zavrtnica 17, Zagreb, Hrvatska |
Marketing Authorisation Date | 14.12.2023 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/23-02/144 |
Registration Number | 381-12-01/171-23-04 |
Prescription | Medicinal product subject to medical prescription |
Type of prescription | neponovljivi recept |
Distribution | Supply through pharmacies (community) |
Advertising to general public | not allowed |
ATC Code | D05AX52 |
Marketing status | stavljeno u promet |
Shortage status | nema nestašice |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |