Rybelsus

RSS

semaglutide

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 10/06/2020

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 monitoringAdditional 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
Marketing-authorisation holder
Novo Nordisk A/S
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
03/04/2020
Contact address

Novo Alle
Bagsværd - 2880
Denmark

Product information

19/05/2020 Rybelsus - EMEA/H/C/004953 - IAIN/0001/G

Contents

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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.

Assessment history

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