Rybelsus
semaglutide
Table of contents
Overview
Rybelsus is a medicine used to control blood glucose (sugar) levels in adults whose type 2 diabetes is not controlled well enough. It can be used on its own when metformin (another medicine for diabetes) cannot be used, or in combination with other diabetes medicines. It should be used with an appropriate diet and physical exercise.
Rybelsus contains the active substance semaglutide.
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List item
Rybelsus : EPAR - Medicine overview (PDF/120.14 KB)
First published: 27/05/2020
EMA/62316/2020 -
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Rybelsus : EPAR - Risk-management-plan summary (PDF/89.87 KB)
First published: 27/05/2020
Authorisation details
Product details | |
---|---|
Name |
Rybelsus
|
Agency product number |
EMEA/H/C/004953
|
Active substance |
semaglutide
|
International non-proprietary name (INN) or common name |
semaglutide
|
Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
Anatomical therapeutic chemical (ATC) code |
A10BJ06
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Novo Nordisk A/S
|
Revision |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
03/04/2020
|
Contact address |
Product information
13/11/2020 Rybelsus - EMEA/H/C/004953 - IB/0010/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
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.