Human medicines European public assessment report (EPAR): Rybelsus, semaglutide, Diabetes Mellitus, Type 2, Date of authorisation: 03/04/2020, Revision: 5, Status: Authorised

Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise

as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
in combination with other medicinal products for the treatment of diabetes.

For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

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Human medicines European public assessment report (EPAR): Rybelsus, semaglutide, Diabetes Mellitus, Type 2, Date of authorisation: 03/04/2020, Revision: 5, Status: Authorised

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