Wegovy

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semaglutide

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

Overview

Wegovy is used together with diet and physical activity to help people to lose weight and keep their weight under control. It is used in adults who have:
• a BMI of 30 kg/m² or greater (obesity) or
• a BMI of at least 27 kg/m² but less than 30 kg/m² (overweight) who have weight-related health problems (such as diabetes, high blood pressure, abnormal levels of fats in the blood, breathing problems during sleep called ‘obstructive sleep apnoea’ or a history of heart attack, stroke or blood vessel problems).
It is also used in adolescents from 12 years of age whose BMI is at or above the 95th percentile for their age and gender (obesity) and who weigh more than 60 kg.
BMI (body mass index) is a measure of your weight in relation to your height. A BMI at the 95th percentile means that it is greater than that of 95% of people of the same age and gender.
Wegovy contains the active substance semaglutide.

This EPAR was last updated on 13/10/2023

Authorisation details

Product details
Name
Wegovy
Agency product number
EMEA/H/C/005422
Active substance
semaglutide
International non-proprietary name (INN) or common name
semaglutide
Therapeutic area (MeSH)
  • Obesity
  • Overweight
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
4
Date of issue of marketing authorisation valid throughout the European Union
06/01/2022
Contact address

Novo Alle 1
2880 Bagsvaerd
Denmark

Product information

11/10/2023 Wegovy - EMEA/H/C/005422 - IB/0015/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antiobesity preparations, excl. diet products

Therapeutic indication

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.

Adolescents (≥12 years)
Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with
• obesity* and
• body weight above 60 kg.

Treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose.

*Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1 in 4.1 of SmPC).

Table 1 BMI cut-off points for obesity (≥95th percentile) by sex and age for paediatric patients aged 12 and older (CDC criteria)

Assessment history

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