🇪🇺 Semaglutide Pill in European Union

EMA authorised Semaglutide Pill on 3 April 2020

Marketing authorisation

EMA — authorised 3 April 2020

  • Application: EMEA/H/C/004953
  • Marketing authorisation holder: Novo Nordisk A/S
  • Local brand name: Rybelsus
  • 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.
  • Status: approved

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Semaglutide Pill in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Semaglutide Pill approved in European Union?

Yes. EMA authorised it on 3 April 2020.

Who is the marketing authorisation holder for Semaglutide Pill in European Union?

Novo Nordisk A/S holds the EU marketing authorisation.