Risk/ benefit- hensyn På basis af den dokumentation, der er indsendt af indehaveren af markedsføringstilladelsen, og de faglige drøftelser i udvalget fandt CPMP, at benefit/ risk- forholdet for Calcichew D3 er gunstigt for brug i relation til forebyggelse og behandling af vitamin D - og calciummangel hos ældre, vitamin D og calciumtilskud gives som adjuverende behandling i forbindelse med behandling af osteoporose hos patienter, der har risiko for vitamin D - og calciummangel.
Benefit/ Risk considerations Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CPMP considered that the benefit/ risk ratio of Calcichew-D3 is favourable for use relating to prevention and treatment of vitamin D and calcium deficiency in the elderly and for use as vitamin D and Calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.