🇪🇺 Semaglutide Pen Injector [Ozempic] in European Union

EMA authorised Semaglutide Pen Injector [Ozempic] on 8 February 2018

Marketing authorisations

Application: EMEA/H/C/004174
Marketing authorisation holder: Novo Nordisk A/S
Local brand name: Ozempic
Indication: Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; in addition to 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

Application: EMEA/H/C/005422
Marketing authorisation holder: Novo Nordisk A/S
Local brand name: Wegovy
Indication: Adults Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of ≥30 kg/m2 (obesity), or ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. For trial results with respect to cardiovascular risk reduction and populations studied, see section 5.1. Adolescen
Status: approved

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

Is Semaglutide Pen Injector [Ozempic] approved in European Union?

Yes. EMA authorised it on 8 February 2018; EMA authorised it on 6 January 2022.

Who is the marketing authorisation holder for Semaglutide Pen Injector [Ozempic] in European Union?

Novo Nordisk A/S holds the EU marketing authorisation.