Medicinal Products

Co-Roswera 15 mg/10 mg filmom obložene tablete

Name Co-Roswera 15 mg/10 mg filmom obložene tablete
Marketing Authorisation Number HR-H-319752844
Active Substance rosuvastatinkalcij
ezetimib
Composition jedna filmom obložena tableta sadrži 15 mg rosuvastatina (u obliku rosuvastatinkalcija) i 10 mg ezetimiba
Pharmaceutical Form filmom obložena tableta
Manufacturer Krka d.d. Novo mesto, Novo Mesto, Slovenija
TAD Pharma Gmbh, Cuxhaven, Njemačka
Marketing Authorisation Holder Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska
Marketing Authorisation Date 25.09.2024
MA Period of Validity unlimited
Classification Number UP/I-530-09/23-02/13
Registration Number 381-12-01/286-24-06
Prescription Medicinal product subject to medical prescription
Type of prescription Medicinal product on medical prescription for renewable delivery
Distribution Supply through pharmacies (community)
Advertising to general public not allowed
ATC Code C10BA06
Marketing status Never marketed
SmPC download
PL download
Public Assessment Report download
Summary of risk management plan download

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