Medicinal Products

Sitagliptin/dapagliflozin Krka d.d. Novo mesto 100 mg/10 mg filmom obložene tablete

Name Sitagliptin/dapagliflozin Krka d.d. Novo mesto 100 mg/10 mg filmom obložene tablete
Marketing Authorisation Number HR-H-039487944
Active Substance sitagliptinfosfat hidrat
dapagliflozin propandiol hidrat
Composition jedna filmom obložena tableta sadrži 100 mg sitagliptina (u obliku sitagliptinfosfat hidrata) i 10 mg dapagliflozina (u obliku dapagliflozin propandiolhidrata)
Pharmaceutical Form Filmom obložena tableta
Manufacturer TAD Pharma Gmbh, Cuxhaven, Njemačka
Krka d.d. Novo mesto, Novo Mesto, Slovenija
Marketing Authorisation Holder Krka d.d. Novo mesto, Šmarješka cesta 6, Novo Mesto, Slovenija
Marketing Authorisation Date 10.04.2025
MA Period of Validity 10.04.2030
Classification Number UP/I-530-09/23-01/352
Registration Number 381-12-01/286-25-07
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 A10BD29
Marketing status Never marketed
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