1. Name of the medicinal product

Rybelsus 14 mg tablets

2. Qualitative and quantitative composition

Each tablet contains 14 mg semaglutide*.

*human glucagon-like peptide-1 (GLP-1) analogue produced in Saccharomyces cerevisiae cells by recombinant DNA technology.

Excipient with known effect

Each tablet, regardless of semaglutide strength, contains 23 mg sodium.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablet

White to light yellow, oval shaped tablet (7.5 mm x 13.5 mm) debossed with '14' on one side and 'novo' on the other side.

5. Pharmacological properties

5.1 Pharmacodynamic properties

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

6. Pharmaceutical particulars

6.1 List of excipients

6.2 Incompatibilities

6.3 Shelf life

6.4 Special precautions for storage

6.5 Nature and contents of container

6.6 Special precautions for disposal and other handling

7. Marketing authorisation holder

8. Marketing authorisation number(s)

9. Date of first authorisation/renewal of the authorisation

10. Date of revision of the text

Country/region

Language